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EC number: 915-672-9 | 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
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation:
In vivo data on THEICTA as mono-constituent substance indicate a low potential for skin irritation while, while TMPTA is subject to an EU harmonised classification as Skin Irrit. 2.
Eye irritation:In vivo data on THEICTA as mono-constituent substance indicate a potential for severe eye irritation/ eye damage resulting in classification as Eye damage 1. Data from eye irritation test on TMPTA indicates an eye irritation potential resulting in a classification as Eye Irrit. 2.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Data on target substance not available. Thus, read-across has been applied using data from the source substance THEICTA (S1) and TMPTA (S2).
See further read-acoss justification in attached document to section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Executive summary:
No data is available for Reaction mass of THEICTA and THEICDA (T).
In vivo data on THEICTA (S1) as mono-constituent substance indicate a low potential for skin irritation while, while TMPTA (S2) is subject to an EU-harmonised classification as Skin Irrit 2. Based on these data Reaction mass of THEICTA and THEICDA may be considered as borderline for skin irritation. Using the data in a precautious way Reaction mass of THEICTA and THEICDA is to be classified as Skin Irrit. 2
See justification for read-across attached in section 13.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- January 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 13-19 weeks if age
- Weight at study initiation: 2.9-3.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes but no details
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of the test substance was applied under a 25 mm x 25 mm gauze pad moistened with 0.5 ml distilled water to one intact skin site of each animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 days
- Number of animals:
- 3
- Details on study design:
- The test substance was administered following grinding using a pestle and mortar.
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water ( 30°C to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
All animals were observed daily for signs of ill health or toxicity.
Dermal examination of the treated skin was made on Day 1 (60 minutes after removal of the dressings) and on Days 2, 3, and 4 (equivalent to 24, 48 and 72 hours after exposure). - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No dermal irritation was observed at 60 min, 24h, 48h and 72h after patch removal.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single semi-occlusive application of the test substance to intact rabbit skin for 4h elicited no dermal irritation.
- Executive summary:
A study was performed to assess the skin irritation potential of the test item to the rabbit. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. No dermal reactions were observed following a single semi-occlusive dermal application of the test substance to intact rabbit skin for four hours. Based on these results, the test substance is considered as not skin irritating.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 July 1996 to 22 July 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 404 with minor deviations: no certificate of analysis, no data on the purity of the test substance, observation period of 7 days instead of 14 days.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline No. 404 adopted in July 1992
- Deviations:
- yes
- Remarks:
- : no certificate of analysis, no data on the purity of the test substance, observation period of reversibility for 7 days instead of 14 days.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Aace animals, Boyertown, PA, USA
- Age at study initiation: about 3 months
- Weight at study initiation: 2.2-2.5 kg
- Housing: individually in wire cages
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet #5321), provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 1996-03-31 to 1996-04-14 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 hours and on day 7 after the removal of the dressing.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 x 25 mm on the dorso area of the trunk
- Type of wrap if used: 25 mm x 25 mm gauze pad covered with a non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing with distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM:
Erythema & Eschar
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1.0 mm) 3
Severe edema (raised more than 1.0 mm, extending beyond the area of exposure) 4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: 24, 48, 72 h
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: 24, 48, 72 h
- Score:
- ca. 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: 24, 48, 72 h
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: 24, 48, 72 h
- Score:
- ca. 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: 24, 48, 72 h
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- Erythema scores ranged from very slight to well defined through 72 hours after patch removal, and from absent to very slight on day 7.
Edema scores ranged from absent to slight through 48 hours after patch removal, and from absent to very slight through day 7.
See details in Table 7.3.1/1 - Other effects:
- For one animal, 48 hours after the removal of the dressing, diarrhea and wetness of the anogenital area were observed. Seven days after the removal of the dressing all animals presented skin flaking.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, SR 351 is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In a dermal irritation GLP study performed according to the OECD guideline No. 404 (approved in July 1992), three young adult male White New-Zealand rabbits were dermally exposed to 0.5 mL of test article for 4 hours to 6.25 cm² of clipped skin in semi-occlusive conditions. Animals then were observed for 7 days. Reactions were scored again at 24, 48 and 72 hours and on day 7. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods.
Under the test conditions, there were slightly irritant effects, with mean individual scores within 24, 48 and 72 hrs of 1.3/1.7/2.0 for erythema and 0.3/0.7/1.3 for edema. These effects were not fully reversible within 7 days for one animal only. Considering these scores the test substance is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
Primary Irritation Index is 2.00
Although the classification criteria in this key study was not met the study has to be assessed with a series of other tests on skin irritation of TMPTA:
Clear skin irritating effects were observed in three skin irritation studies according to OECD guideline. The
scores obtained from the study led to no classification according to CLP EC 1272/2008 as the mean value are
below 2.3 for erythema/eschar or oedema in at least 2 of 3 animals and as the inflammation does not persist in 2
animals over a 14 day observation period.
Nevertheless, there is an EU harmonised (CLP annex VI) classification as Skin irrit 2 and thus this classification should be applied for TMPTA.
Referenceopen allclose all
Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema and Eschar formation |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1h |
1/1/2 |
0/0/2 |
24 h |
1/2/2 |
0/1/1 |
48 h |
2/2/2 |
1/1/2 |
72 h |
1/1/2 |
0/0/1 |
Average 24h, 48h, 72h |
1.3/1.7/2 |
0.3/0.7/1.3 |
Reversibility (within 7 days)a |
n.c.b |
n.c. |
Average time (unit) for reversion |
? |
? |
aReversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
bFlaking skin
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well conducted and documented study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: In general the techniques of tests as published by the FDA af the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Gosmet. Industr. 71 (1952) 36) are followed.
- Principles of method if other than guideline:
- Principles according to Draize
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Ihe animais are caged individually and receive no hay or other extranous material that might enter the eyes
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: second eye serves as control
- Amount / concentration applied:
- - undiluted
- 100µL - Duration of treatment / exposure:
- Treatment: After installtion the upper and lower eye lid are then carefully clased and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye remaining untreated, serves as a control.The eyes are not washed following instillation and the animals
are released immediately. - Observation period (in vivo):
- The eyes are examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material.
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- Ocular reactions are judged using the scoring seale as published by Draize and Kelley (Drug. Gosmet. Industr. 71 (1952) 36)
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: highest value of 3 after 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: 48h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: highest value of 3 after 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: highest value of 3 after 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- other: 48h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- other: 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 48h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 72h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 48h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 72h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 48h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 24h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 48h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- no corrosive effects reported
- Interpretation of results:
- other:
- Conclusions:
- From the present results it can be coneluded that the compound na. 77/767 is moderately irritating to the eye.
- Executive summary:
A eye irritation study according to the general techniques as published by the FDA of the(Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Gasmet. Industr. 71 (1952) 36) was conducted to assess the eye irritation potential of TMPTA.
Therefore two New Zealand White albino rabbits received 100 milligrams of the test substance. No washout followed the instillation and the eyes are examined at one hour, 24, 48, 72 hours and 7 days. Ocular reactions are judged using the scoring scale as published by Draize and Kelley (Drug. Gosmet. Industr. 71 (1952) 36)
During the first day after instillation the eyes showed slight corneal damage, slight iritis and moderate to severe lesions of the conjunctivae.
In the course of the seven-day observation period the degree of corneal
damage increased. After seven days the following ocular lesions were observed: moderate or moderate-severe corneal opacity, slight iritis and moderate conjunctivitis.
The author concluded that, according to the classification used, the test material is moderately irritating to the eye.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Data on target substance not available. Thus, read-across has been applied using data from the source substance THEICTA (S1) whcih is the mnain constituent in the target substance and TMPTA (S2).
See further read-acoss justification in attached document to section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- associated with haemorrhage and necrosis
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- associated with nictating membrane swollen
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In vivo study in rabbit, performed according to the EU.B.5. guideline THEICTA (S1) suggest that the targent substance Reaction mass of THEICTA and THEICDA should be classified as Eye damage 1.
- Executive summary:
In vivo data on THEICTA as mono-constituent substance indicate a potential for severe eye irritation/ eye damage resulting in classification as Eye damage 1. In vivo data from eye irritation test on TMPTA indicates an eye irritation potential resulting in a classification as Eye Irrit. 2. Thus, due to the high content of THEICTA in Reaction mass of THEICTA and THEICDA a classification as Eye damage 1 should be apply for Reaction mass of THEICTA and THEICDA.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 13 weeks if age
- Weight at study initiation: 2.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes but no details
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg of the test substance was placed into the lower everted lid of one eye of each animal.
The eyelids were ten gently held together for one second before releasing. The contralateral eye remained untreated. - Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 1 hour and 1 day after exposure
- Number of animals or in vitro replicates:
- 1 animal
- Details on study design:
- The eyes were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated initially, to ensure that if a severe response was produced, no further animals would be exposed. On this occasion, due to the severity of the reactions, no further animals were used.
The animal was observed daily for signs of ill health or toxicity.
Examination of the eyes was made after 1 hour and on two occasions one day after instillation. Observation of the eyes was aided by the use of a handheld light. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- associated with necrosis and haemorrhage
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- associated with nictating membrane swollen
- Irritant / corrosive response data:
- Corneal opacities developed one day after instillation.
Iridial inflammation (grade 2) was observed.
A diffuse crimson or beefy red colouration of the conjunctivae accompanied by swelling with the eyelids more than half closed was seen. Necrosis and haemorrhage was seen on the nictating membrane and lower eyelid. A red/brown discharge was also seen before the animal was killed.
Due to the severity of the reactions, the animal was killed one day after instillation and no further animals were treated. - Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the available results, the test substance is considered as severely eye irritating to the rabbit.
- Executive summary:
A study was performed to assess the eye irritation of the test substance to the rabbit. One rabbit was administered a single ocular dose of 100 mg of the test substance and observed for one day after instillation. A single installation of the test substance into the eye of the rabbit elicited corneal opacification, severe iridial inflammation and conjunctival reactions. The animal was killed one day after instillation. Based on the available results, the test substance is considered as severely eye irritating to the rabbit.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Eye irritation:
An eye irritation study with THEICTA (S1) as monoconstituent in rabbit performed according to the EU .B.5. guideline where one rabbit was administered a single ocular dose of 100 mg of the test substance and observed for one day after instillation. A single installation of the test substance into the eye of the rabbit elicited corneal opacification, severe iridial inflammation and conjunctival reactions. The animal was killed one day after instillation. Based on the available results, the test substance is considered as severely eye irritating to the rabbit.
Justification for classification or non-classification
Skin irritation:
In vivo data on THEICTA as mono-constituent substance indicate a low potential for skin irritation while, while TMPTA is subject to an EU harmonised classification as Skin Irrit. 2.
Based on these data Reaction mass of THEICTA and THEICDA (T) may be considered as borderline for skin irritation.Using the data in a precautious way Reaction mass of THEICTA and THEICDA is to be classified as Skin Irrit. 2
Eye irritation:
In vivo data on THEICTA as mono-constituent substance indicate a potential for severe eye irritation/ eye damage resulting in classification as Eye damage 1. Data from eye irritation test on TMPTA indicates an eye irritation potential resulting in a classification as Eye Irrit. 2.
Thus, due to the high content of THEICTA in Reaction mass of THEICTA and THEICDA a classification as Eye damage 1 should be apply for Reaction mass of THEICTA and THEICDA.
Classification for Reaction mass of THEICTA and THIECDA:
Skin: GHS classification (Skin irrit 2, H315).
Eye: GHS classification (Eye damage 1, H318).
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