Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
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- Auto flammability
- Flammability
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- Oxidation reduction potential
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Endpoint summary
Administrative data
Description of key information
Data are available from in vivo skin and eye irritation studies conducted using a diluted form of the registered substance. These studies were conducted prior to the adoption of the relevant OECD Guidelines and have some differences in design compared to current Guidelines. However, the studies are well documented and considered sufficient for assessment.
In the skin irritation study in rabbits, at the 24-hour time point well-defined erythema to severe erythema was observed at both intact and abraded test sites, as well as edema ranging from moderate to severe. At the 72 -hour time point, no edema was noted but erythema ranged from well-defined to severe.
In the eye irritation study, positive reactions were noted in the treated eyes of all six rabbits at the 24, 48 and 72 hour readings. Some of the effects (cornea, iris) were reversible within 72 hours in some animals. However, the conjunctiva effects (erythema, chemosis, discharge) were not reversible within this time period.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29/10/1980 to 1/11/1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This primary dermal irritation study was conducted prior to the adoption of OECD Guideline 404 (original adopted in 1981). However, the study was conducted in accordance with the test facility protocol and US FHSA guidelines available at the time. Study methods and results are well documented in the study report and summarised here.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test material is 65% of the registered substance diluted in 35% non-hazardous mineral oil. Described in the study reports as a thick, brown oily liquid.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: B&D Commercial Rabbitry, Malvern, Arkansas
- Age at study initiation: At least 8 weeks old
- Weight at study initiation: 2507-2866 g
- Housing: Individually housed in stainless steel cages, which are elevated above the droppings, in an environmentally controlled room. Rooms and cages maintained in accordance with the standards of the American Association for Accredication of Laboratory Animal Care (AAALAC).
- Diet: Wayne Feeds Rabbit Ration available ad libitum
- Water: Tap water available ad libitum
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: To: 29/10/1980 to 1/11/1980 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Fur was clipped from the dorsal area of the test animnals at least 24 hours prior to application. Two test sites were used per animal; one site was abraded using a hypodermic needle immediately prior to dosing. The skin of the other site was left intact.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml per test site - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- Six; 3 females and 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 3 cm2 per test site
- % coverage: Not reported
- Type of wrap if used:
Each dose was introduced under a square patch of surgical gauze measuring 1 inch by 1 inch and two single layers thick. Patches secured in place with Coban elastic bandage and Johnson and Johnson Zonas porous adhesive tape. The entire trunk of each animal was then wrapped with an impervious non-reactive material (such as plastic, 2 mils thick) and sealed at both ends to retard evaporation of volatile substances and to prevent the ingestion of the test material. A white cotton towel (15cm x 45cm) was then wrapped over the plastic and secured with Johnson and Johnson Zonas porous tape.
REMOVAL OF TEST SUBSTANCE
After the 24-hour exposure, the patches were removed and the skin was wiped, but not washed (unless necessary to observe the skin) to remove any test substance still remaining.
OBSERVATION TIME POINTS
A 30-minute period was allowed following removal of the test substance for pressure and hydration effects to subside. The animals were then scored for dermal reactions. Test sites were scored again after an additional 48 hours (i.e. 24 and 72-hour time points).
SCORING SYSTEM:
Irritation potential was scored according to the method of Draize (1944), as outlined in the Federal Hazardous Substances Act Grading Code at 16 CFR 1500.41. Primary irritation score was calculated as the total of the average scores for erythema / eschar formation and edema formation at 24- and 72-hours in either intact or abraded skin (8 values) divided by 4. - Irritation parameter:
- overall irritation score
- Basis:
- other: Primary Irritation score = Total of average scores / 4
- Time point:
- other: 24/72 hr
- Score:
- 5.38
- Reversibility:
- not specified
- Remarks on result:
- other: Primary dermal irritant
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Moderate to severe erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Well-defined erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Well-defined erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Moderate to severe erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Moderate to severe erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Moderate to severe erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Moderate to severe erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.83
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Well-defined erythema
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Well-defined erythema
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Moderate edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- probability of severe irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Moderate edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- probability of severe irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Other effects:
- No abnormal behaviour was noted in any animal during the conduct of this study.
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- A primary irritation score of 5.38 was calculated. The test substance was therefore considered to be a primary dermal irritant according to the FHSA Regulations at 16 CFR 1500.3, as referenced in the study report. Severe erythema was observed at both the 24- and 72-hour timepoints in intact and abraded skin. Severe edema was noted at the 24-hour time point but was reversible within 72-hours. Due to the lack of 14-day observation period in this study, it is unclear whether the erythema would be reversible after a longer period of time. Therefore, as a worst case, the test substance is classified as Category 1 for skin corrosion/irritation under GHS and CLP. There is insufficient information to subcategorise.
- Executive summary:
A study was conducted in order to evaluate the dermal irritation potential of the test substance in six New Zealand White rabbits (3/sex). The test sites were prepared by clipping the fur (dorsal trunk area) 24 hours prior to treatment. Two test sites (each approximately 3 cm2) were prepared within the clipped area per animal; one to the left of the spinal column and one to the right, with at least 3 cm of separation between test sites. On one site the skin was abraded immediately prior to treatment and on the other the skin was left intact. A dose of 0.5 ml test substance was applied to each site under semi-occlusive conditions for 24 hours. Following the exposure period, the test area was wiped and a 30 -minute period allowed for pressure and hydration effects to subside. The test areas were then scored for dermal reactions (erythema and edema). The animals were observed for an additional 48 hours (72 hours total) and the dermal reactions were then scored again. At the 24-hour time point, well-defined erythema to severe erythema was observed at both the intact and abraded test sites, as well as edema ranging from moderate to severe. At the 72 -hour time point, erythema ranged from well-defined to severe but no edema was noted. Due to the lack of 14-day observation period in this study, it is unclear whether the erythema would be reversible after a longer period of time. Therefore, as a worst case, the test substance is classified as Category 1 for skin corrosion/irritation under GHS and CLP. There is insufficient information to subcategorise.
Reference
Primary irritation scores in six rabbits following a 24 -hour exposure:
Skin condition |
Time (hr) |
Animal number / sex |
Total score |
Average score |
|||||
|
1/M |
2/M |
3/M |
4/F |
5/F |
6/F |
|||
Erythema and Eschar formation |
|||||||||
Intact |
24 |
4 |
2 |
4 |
4 |
4 |
4 |
22 |
3.67 |
Intact |
72 |
3 |
2 |
3 |
3 |
3 |
3 |
17 |
2.83 |
Abraded |
24 |
4 |
2 |
4 |
4 |
4 |
4 |
22 |
3.67 |
Abraded |
72 |
4 |
2 |
4 |
4 |
4 |
4 |
22 |
3.67 |
Edema formation |
|||||||||
Intact |
24 |
4 |
3 |
4 |
4 |
4 |
4 |
23 |
3.83 |
Intact |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
24 |
4 |
3 |
4 |
4 |
4 |
4 |
23 |
3.83 |
Abraded |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Oct 1980 to 1 Nov 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This acute eye irritation study was conducted prior to the adoption of OECD Guideline 405 (original adopted in 1981). However, the study was conducted in accordance with the test facility protocol and US FHSA guidelines available at the time. Study methods and results are well documented in the study report and summarised here.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test material is 65% of the registered substance diluted in 35% non-hazardous mineral oil. Described in the study reports as a thick, brown oily liquid.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: B and D Commercial Rabbitry, Malvern, Arkansas
- Age at study initiation: Young adults, at least 8 weeks old
- Weight at study initiation: 2424 -2843 g
- Housing: Individual housing in stainless steel cages, which were elevated above the droppings, in an environmentally controlled room. Rooms and cages maintained in accordance with the standards of the American Association for Accredication of Laboratory Animal Care (AAALAC). Sawdust, wood chips and other extraneous materials that might produce eye irritation were excluded from the animal facilities.
- Diet (e.g. ad libitum): Wayne Feeds Rabbit Ration available ad libitum
- Water (e.g. ad libitum): Tap water available ad libitum
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 29 Oct 1980 To: 1 Nov 1980 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of undiluted test material - Duration of treatment / exposure:
- Single instillation into the conjunctival sac of the right eye. The lid was held together for one second to insure adequate distribution of the test material. Observations for eye irritation were made after 24, 48 and 72 hours. Left eye remained untreated and served as the control.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Six; 3 females and 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The treated eye was not irrigated.
SCORING SYSTEM: Method of Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope /
In addition to regular eye examination, the treated eyes of all animals were examined after application of sodium fluorescein 72 hours post treatment. The reading of reactions was facilitated by ophthalmoscopy. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Scattered or diffuse areas, details of iris clearly visible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Scattered or diffuse areas, details of iris clearly visible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Scattered or diffuse areas, details of iris clearly visible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Scattered or diffuse areas, details of iris clearly visible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Easily discernible translucent areas, details of iris slightly obscured
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- other: Not applicable (no effects)
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- other: Not applicable (no effects)
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- other: Not applicable (no effects)
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- other: Not applicable (no effects)
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Scattered or diffuse areas, details of iris clearly visible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- other: Not applicable (no effects)
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- other: Not applicable (no effects)
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- other: Not applicable (no effects)
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- other: Not applicable (no effects)
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Scattered or diffuse areas, details of iris clearly visible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- More diffuse, deeper crimson red, individual vessels not easily discernible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- More diffuse, deeper crimson red, individual vessels not easily discernible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- More diffuse, deeper crimson red, individual vessels not easily discernible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- More diffuse, deeper crimson red, individual vessels not easily discernible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- More diffuse, deeper crimson red, individual vessels not easily discernible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- More diffuse, deeper crimson red, individual vessels not easily discernible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Vessels definitely injected above normal
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Swelling with lids about half closed to completely closed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with lids about half closed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with lids about half closed
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Swelling with lids about half closed to completely closed
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with lids about half closed
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with lids about half closed
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with lids about half closed
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- Obvious swelling with partial eversion of lids
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 38
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 31
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 16
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 33
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 31
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 41
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 19
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 19
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 14
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 17
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 22
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 12
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 17
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 17
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 17
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 19
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 22
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 17
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- Positive reactions were noted in the treated eyes of all six rabbits at the 24, 48 and 72 hour readings. In some animals, the cornea and iris effects were reversible within 72 hours, but this was not the case with the conjunctiva effects (erythema, chemosis, discharge) in any animal.
- Other effects:
- No abnormal appearance or behaviour was noted during the conduct of this study.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Positive reactions were noted in the treated eyes of all six rabbits at the 24, 48 and 72 hour readings. Therefore, when instilled into the eyes of albino rabbits the test substance was considered to be a primary irritant as defined in the FHSA Regulations at 16 CFR 1500.3, as referenced in the study report. Some of the effects (cornea, iris) were reversible within 72 hours in some animals. However, the conjunctiva effects (erythema, chemosis, discharge) were not reversible within this time period. Since a 21-day observation period (as recommended by the current OECD Guideline) was not included in this study, it is unclear whether the remaining irritation effects would be reversible after a longer period of time. Therefore, as a worst case, the test substance is classified as Category 1 for effects on the eye under GHS and CLP.
- Executive summary:
A study was conducted in order to evaluate the eye irritation potential of the test substance in six New Zealand White rabbits (3/sex). The test substance was instilled into the conjunctival sac of the right eye of each animal. The lid was held together for one second to insure adequate distribution of the test material. Observations for eye irritation were made after 24, 48 and 72 hours. Positive reactions were noted in the treated eyes of all six rabbits at the 24, 48 and 72 hour readings. Some of the effects (cornea, iris) were reversible within 72 hours in some animals. However, the conjunctiva effects (erythema, chemosis, discharge) were not reversible within this time period. Since a 21-day observation period (as recommended by the current OECD Guideline) was not included in this study, it is unclear whether the remaining irritation effects would be reversible after a longer period of time. Therefore, as a worst case, the test substance is classified as Category 1 for irreversible effects on the eye under GHS and CLP.
Reference
Rabbit |
Time (hours) |
Cornea |
Iris |
Conjunction |
Total score |
|||
Opacity |
Area |
Iritis |
Erythema |
Chemosis |
Discharge |
|||
1 |
24 |
1 |
3 |
1 |
2 |
4 |
3 |
38 |
48 |
1 |
2 |
1 |
2 |
3 |
3 |
31 |
|
72 |
0 |
0 |
0 |
2 |
3 |
3 |
16 |
|
2 |
24 |
1 |
2 |
1 |
2 |
4 |
3 |
33 |
48 |
1 |
2 |
1 |
2 |
3 |
3 |
31 |
|
72 |
2 |
2 |
1 |
2 |
3 |
3 |
41 |
|
3 |
24 |
0 |
0 |
1 |
1 |
2 |
4 |
19 |
48 |
0 |
0 |
1 |
1 |
2 |
4 |
19 |
|
72 |
0 |
0 |
0 |
1 |
3 |
3 |
14 |
|
4 |
24 |
0 |
0 |
1 |
1 |
2 |
3 |
17 |
48 |
1 |
1 |
1 |
1 |
2 |
3 |
22 |
|
72 |
0 |
0 |
0 |
1 |
2 |
3 |
12 |
|
5 |
24 |
0 |
0 |
1 |
1 |
2 |
3 |
17 |
48 |
0 |
0 |
1 |
1 |
2 |
3 |
17 |
|
72 |
0 |
0 |
1 |
1 |
2 |
3 |
17 |
|
6 |
24 |
0 |
0 |
1 |
1 |
2 |
4 |
19 |
48 |
1 |
1 |
1 |
1 |
2 |
3 |
22 |
|
72 |
0 |
0 |
1 |
1 |
2 |
3 |
17 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Since 14 -day and 21 -day observation periods were not included in the skin and eye irritation studies, respectively, as recommended by current OECD Guidelines, it is unclear whether the irritation effects observed would be reversible after a longer period of time. Therefore, as a worst case, classifications of Category 1 for skin corrosion/irritation and for irreversible effects on the eye are appropriate under Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures. There is insufficient information to subcategorise for skin corrosion/irritation
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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