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Diss Factsheets

Administrative data

Description of key information

The skin irritation/corrosion study with the test item in the rabbit revealed no irreversible effects.

The acute eye irritation/corrosion study with the test item in the rabbit revealed no irreversible effects.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
other: ECHA provided robust study summary
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal: #1 - 3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 21 day
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 21 days
Other effects:
Scaliness was observed after 7 days, this resolved within 21 days and was considered to be a reversible skin reaction.
Interpretation of results:
other: not classified Migrated information
Remarks:
Criteria used for interpretation of results:EU
Conclusions:
The primary skin irritation/corrosion study with the test item in the rabbit revealed no irreversible effects.
Executive summary:

The primary skin irritation/corrosion study with the test item in the rabbit (4-hour semi-occlusive application) was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.4, "Acute Toxicity - Skin irritation". Three rabbits were exposed to 500g of the test item, applied onto skin for 4 hours using a semi-occlusive dressing. Observations were made 24, 48 and 72 hours after exposure. Exposure resulted in well-defined erythema and very slight oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 7 days after exposure in all animals. Erythema at the edges of the application-area and scaliness were observed 72 hours and/or 7 days after exposure. The scaliness, as observed after 7 days, was considered to be reversible skin reaction that resolves within the full study period of 21 days.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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:
other: ECHA provided robust study summary
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100%
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scoring system
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 14 days
Other effects:
Reduced elasticity of the eyelids. Pannus, neovascularisation of the cornea.
Interpretation of results:
other: not classified Migrated information
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The acute eye irritation/corrosion study with the test item in the rabbit revealed no irreversible effects.
Executive summary:

The acute eye irritation/corrosion study with the test item in the rabbit was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.5, "Acute Toxicity - Eye irritation". Single samples of 0.1 mL of the test item were instilled into one eye of each of three rabbits. Observations were made 24, 48 and 72 hours and 14 days after instillation. Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae, in two animals corneal injury was seen as opacity (maximum grade 1) and epithelial damage. In all animals iridial irritation (grade 1) was observed. In all animals irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in one animal and within 14 days in the other two animals. Reduced elasticity was observed in one animal at 72 hours and 7 days. All effects were reversible after 14 days.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The primary skin irritation/corrosion study with the test item in the rabbit (4-hour semi-occlusive application) was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.4, "Acute Toxicity - Skin irritation". Three rabbits were exposed to 500g of the test item, applied onto skin for 4 hours using a semi-occlusive dressing. Observations were made 24, 48 and 72 hours after exposure. Exposure resulted in well-defined erythema and very slight oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 7 days after exposure in all animals. Erythema at the edges of the application-area and scaliness were observed 72 hours and/or 7 days after exposure. The scaliness, as observed after 7 days, was considered to be reversible skin reaction that resolves within the full study period of 21 days.

The acute eye irritation/corrosion study with the test item in the rabbit was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.5, "Acute Toxicity - Eye irritation". Single samples of 0.1 mL of the test item were instilled into one eye of each of three rabbits. Observations were made 24, 48 and 72 hours and 14 days after instillation. Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae, in two animals corneal injury was seen as opacity (maximum grade 1) and epithelial damage. In all animals iridial irritation (grade 1) was observed. In all animals irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in one animal and within 14 days in the other two animals. Reduced elasticity was observed in one animal at 72 hours and 7 days. All effects were reversible after 14 days.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on eye and skin irritation/corrosion the test item is not classified and labelled as irritant /corrosive according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.