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EC number: 230-386-8 | CAS number: 7085-19-0
- 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: Kirsch (1983)
Under the conditions of this study, the test material was not classified in accordance with EU criteria.
Eye irritation In Vivo: Kirsch (1983)
Under the conditions of this study, the test material was classified in accordance with EU criteria.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Justification for type of information:
- An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. 38, No. 187, Section 1500.41, P.27019
- Version / remarks:
- Sept. 27, 1973
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Males: 2.97 kg, females: 3.13 kg (mean weights)
- Housing: Cages were made of stainless steel with wire mesh walk floors. Floor area: 40 cm x 51 cm. Animals were housed 1 per cage. No bedding in the cages; sawdust in the waste trays.
- Diet: About 130 g per animal per day
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study in the animal care unit; same housing conditions as during the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidity: 30 to 70 % relative humidity
- Photoperiod: 12 hours light/ 12 hours dark (06.00 - 18.00 hours/ 18.00 - 06.00 hours) - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped (intact and abraded)
- Vehicle:
- water
- Remarks:
- Distilled water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: Around 0.5 g of test material.
NEGATIVE CONTROL
- Amount(s) applied: Untreated skin sites of the same animals were used as negative controls. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 15 days
- Number of animals:
- 2 males and 4 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm on intact and abraded skin. Fur was clipped at least 15 hours before the application of the test material.
- The test patch (2.5 x 2.5 cm) was covered with about a 0.5 mm layer of the 50 % suspension (about 0.5 g of test material).
- Application site: Upper third of the back or flanks.
REMOVAL OF TEST SUBSTANCE
- Test material is wiped off after 24 hours.
OBSERVATION TIME POINTS
- 30 to 60 minutes after removal of the test patches and 48 h, 72 h, 8 d and 15 d after the beginning of the test material application.
SCORING SYSTEM:
- Draize method.
ADDITIONAL EXAMINATIONS
- After sacrifice the animals are examined by gross pathology. If there are clinical signs of necroses, these are confirmed by gross pathological examination after incision of the skin. If there are differences between clinical and pathological findings, only the latter are included in the final report. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: abraded skin
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study, the test material was not classified in accordance with EU criteria.
- Executive summary:
The potential of the test material to cause irritation to the skin of rabbits was investigated in accordance with Fed. Reg. 38, No. 187, Section 1500.41, P.27019, a study similar in design to OECD 404.
Six Vienna white rabbits (two males and four females) were treated with a 50 % w/w aqueous formulation of the test material for 24 hours under an occlusive dressing. The test sites were observed for 15 days following application and assessed using the Draize scale.
Under the conditions of this study, the test material was not classified in accordance with EU criteria.
Referenceopen allclose all
Summary of Results
Readings |
Animal |
Intact Skin |
Abraded Skin |
Individual Irritation Index |
||||
Erythema (E) |
Oedema (ED) |
Symtpoms |
Erythema (E) |
Oedema (ED) |
Symtpoms |
|||
24 hours |
1 |
2 |
2 |
- |
2 |
2 |
HE |
4.0 |
2 |
2 |
2 |
- |
2 |
3 |
HE |
4.5 |
|
3 |
2 |
3 |
- |
2 |
3 |
- |
5.0 |
|
4 |
2 |
1 |
- |
2 |
1 |
- |
3.0 |
|
5 |
2 |
1 |
- |
2 |
1 |
- |
3.0 |
|
6 |
2 |
1 |
- |
2 |
2 |
- |
3.5 |
|
Mean |
2.0 |
1.7 |
|
2.0 |
2.0 |
|
3.8 |
|
48 hours |
1 |
2 |
1 |
HE |
2 |
2 |
HE |
3.5 |
2 |
2 |
1 |
HE |
2 |
2 |
HE |
3.5 |
|
3 |
2 |
1 |
- |
2 |
2 |
|
3.5 |
|
4 |
2 |
1 |
- |
2 |
1 |
|
3.0 |
|
5 |
2 |
1 |
- |
2 |
1 |
|
3.0 |
|
6 |
2 |
1 |
- |
2 |
2 |
|
3.5 |
|
Mean |
2.0 |
1.0 |
|
2.0 |
1.7 |
|
3.3 |
|
72 hours |
1 |
2 |
1 |
HE |
2 |
2 |
HE |
3.5 |
2 |
2 |
1 |
- |
2 |
2 |
HE |
3.5 |
|
3 |
2 |
1 |
- |
2 |
2 |
|
3.5 |
|
4 |
2 |
1 |
- |
2 |
1 |
|
3.0 |
|
5 |
2 |
0 |
- |
2 |
1 |
|
2.5 |
|
6 |
2 |
1 |
- |
2 |
2 |
HE |
3.5 |
|
Mean |
2.0 |
0.8 |
|
2.0 |
1.7 |
|
3.3 |
|
8 days |
1 |
1 |
0 |
S |
1 |
0 |
S |
1.0 |
2 |
0 |
0 |
S |
1 |
0 |
S |
0.5 |
|
3 |
* |
* |
S2 |
* |
* |
S2 |
- |
|
4 |
1 |
0 |
S |
1 |
0 |
S |
1.0 |
|
5 |
0 |
0 |
S |
1 |
0 |
S |
0.5 |
|
6 |
0 |
0 |
- |
1 |
0 |
S |
0.5 |
|
Mean |
0.3 |
0 |
|
1.0 |
0 |
|
0.7 |
|
15 days |
1 |
0 |
0 |
S |
0 |
0 |
S |
0 |
2 |
0 |
0 |
S |
0 |
0 |
S |
0 |
|
3 |
* |
* |
S2 |
* |
* |
S2 |
- |
|
4 |
0 |
0 |
S |
0 |
0 |
S |
0 |
|
5 |
0 |
0 |
S |
0 |
0 |
S |
0 |
|
6 |
0 |
0 |
S |
0 |
0 |
S |
0 |
|
Mean |
0 |
0 |
|
0 |
0 |
|
0 |
Primary irritation index =42.5/12 = 3.5
S2 = Death not due to test material
HE = Haemorrhagic
S = Scaling
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Justification for type of information:
- An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. 38, No. 187, Section 1500.42, P.27019
- Version / remarks:
- Sept. 27, 1973
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males: 3.28 kg, females: 2.85 kg (mean weights).
- Housing: Cages were made of stainless steel with wire mesh walk floors. Floor area: 40 x 51 cm. Animals were housed 1 per cage. No bedding in the cages; sawdust in the waste trays.
- Diet: About 130 g per animal per day
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study in the animal care unit; same housing conditions as during the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidity: 30 to 70 % relative humidity
- Photoperiod: 12 hours light/ 12 hours dark (06.00 - 18.00 hours/ 18.00 - 06.00 hours) - Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL bulk volume (about 54 mg of the comminuted test material) - Duration of treatment / exposure:
- The test material was not washed out.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- The test material was not washed out.
SCORING SYSTEM:
- Based on the Draize appraisal.
- Readings were performed at 1, 24, 48 and 72 hours after application. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Interpretation of results:
- other: EU Category 1, H318: Causes serious eye damage
- Conclusions:
- Under the conditions of this study, the test material was classified in accordance with EU criteria.
- Executive summary:
The potential of the test material to cause irritation to the eyes of rabbits was investigated in accordance with Fed. Reg. 38, No. 187, Section 1500.42, P.27019, a study similar in design to OECD 405.
Six Vienna white rabbits (three males and three females) were treated with an application of 0.1 mL (~54 mg) of test material into the conjunctival sac of the right eyelid. The untreated eye served as a negative control. The eyes were observed for 72 hours following application and assessed using the Draize scale.
Under the conditions of this study, the test material was classified.
Referenceopen allclose all
Summary of Results
Readings |
Animal |
Cornea |
Iris |
Conjunctivae |
Symptoms |
Individual Irritation Index |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|||||
1 hour |
1 |
1 |
4 |
1 |
2 |
2 |
2 |
PC |
37 |
2 |
2 |
4 |
1 |
2 |
2 |
3 |
PC |
59 |
|
3 |
2 |
4 |
1 |
2 |
2 |
2 |
PC |
57 |
|
4 |
1 |
4 |
1 |
2 |
2 |
2 |
- |
37 |
|
5 |
1 |
4 |
1 |
2 |
2 |
3 |
PC |
39 |
|
6 |
2 |
4 |
1 |
2 |
2 |
2 |
PC |
57 |
|
Mean |
|
48 |
|||||||
24 hours |
1 |
2 |
4 |
2 |
3 |
2 |
3 |
PC/S/RE |
66 |
2 |
3 |
4 |
2 |
3 |
2 |
2 |
PC/S/DC |
84 |
|
3 |
2 |
4 |
2 |
3 |
2 |
3 |
PC/S/DC/RE |
66 |
|
4 |
2 |
4 |
2 |
3 |
2 |
3 |
PC/S/DC |
66 |
|
5 |
2 |
4 |
2 |
3 |
2 |
3 |
PC/S/DC |
66 |
|
6 |
2 |
4 |
2 |
3 |
3 |
3 |
PC/S/DC |
68 |
|
Mean |
|
69 |
|||||||
48 hours |
1 |
2 |
4 |
2 |
3 |
3 |
3 |
PC/S/RE/DC |
68 |
2 |
3 |
4 |
2 |
3 |
3 |
3 |
PC/S/DC |
88 |
|
3 |
3 |
4 |
2 |
3 |
3 |
2 |
PC/S/DC/RE |
86 |
|
4 |
2 |
4 |
2 |
3 |
2 |
3 |
PC/S/DC/RE |
66 |
|
5 |
2* |
4* |
2* |
3* |
3 |
3 |
S1 |
68 |
|
6 |
2 |
4 |
2 |
3 |
3 |
3 |
PC/S/DC/RE |
68 |
|
Mean |
|
74 |
|||||||
72 hours |
1 |
3 |
4 |
2 |
3 |
3 |
3 |
PC/S/RE/DC/S3 |
88 |
2 |
3* |
4* |
2* |
3* |
4 |
3 |
S1/S3 |
90 |
|
3 |
3 |
4 |
2 |
3 |
3 |
3 |
PC/S/DC/RE/MV/S3 |
88 |
|
4 |
3 |
4 |
2 |
3 |
3 |
3 |
PC/S/DC/RE/MV/S3 |
88 |
|
5 |
3* |
4* |
2* |
3* |
4 |
3 |
S1/S3 |
90 |
|
6 |
3 |
4 |
2 |
3 |
3 |
3 |
PC/S/DC/RE/MV/S3 |
88 |
|
Mean |
|
89 |
1392 / 18 = 77 (rounded to the nearest whole number). Primary irritation index is about 77.
* = If in 1 - 5 animals assessments referring to the same characteristic cannot be made at a particular reading, the mean rounded to the nearest whole number of the values that can be read is inserted instead.
S1 = Irritation index could not be read because of suppuration
S3 = Study discontinued after 72 hours because of severe irritation
DC = Detachment of the cornea
MV = Marginal vascularization of the cornea
PC = Pupil contracted
RE = Small retractions in the eyelids
S = Suppuration
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation In Vivo: Kirsch (1983)
The potential of the test material to cause irritation to the skin of rabbits was investigated in accordance with Fed. Reg. 38, No. 187, Section 1500.41, P.27019, a study similar in design to OECD 404. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
Six Vienna white rabbits (two males and four females) were treated with a 50 % w/w aqueous formulation of the test material for 24 hours under an occlusive dressing. The test sites were observed for 15 days following application and assessed using the Draize scale.
Under the conditions of this study, the test material was not classified in accordance with EU criteria.
Skin Irritation In Vitro: Waiver
An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available.
Eye Irritation In Vivo: Kirsch (1983)
The potential of the test material to cause irritation to the eyes of rabbits was investigated in accordance with Fed. Reg. 38, No. 187, Section 1500.42, P.27019, a study similar in design to OECD 405. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
Six Vienna white rabbits (three males and three females) were treated with an application of 0.1 mL (~54 mg) of test material into the conjunctival sac of the right eyelid. The untreated eye served as a negative control. The eyes were observed for 72 hours following application and assessed using the Draize scale.
Under the conditions of this study, the test material was classified in accordance with EU criteria.
Eye Irritation In Vitro: Waiver
An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin irritation but does require classification with respect to eye irritation (EU Category 1, H318: Causes serious eye damage).
In accordance with Annex VI of Regulation (EC) No 1272/2008, the substance has a harmonised classification for skin irritation (EU Category 2, H315: Causes skin irritation).
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