Registration Dossier

Administrative data

Description of key information

Skin irritation: Key study: Test method similar to OECD 404. The mean primary irritation score of the test item in rabbits was determined to be 0.9 (lower than 5) and thus, it was concluded not be an skin irritant.

Eye irritation: Key study: Test method similar to OECD 405. The mean eye irritation score in rabbits was determined to be 0 and thus, the test item was concluded not to be an eye irritant.

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:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
poorly documented
GLP compliance:
no
Specific details on test material used for the study:
Purity of each material was checked in the Organic Chemicals Synthesis Laboratory, AEQI, in Beltsville by gas chromatography: > 98%
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9-3.1 kg
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
The hair was clipped from the back and flanks of each of 6 rabbits, and two sites located lateral to the midline of the back and approximately 10 cm apart were selected for the test; one site was abraded by making four epidermal incisions, two perpendicular to the other two. A 0.5-ml dose of undiluted test material was applied to each site. The sites were immediately covered with 2-in.-square gauze patches that were secured with masking tape, and the trunk of each animal was wrapped with plastic sheeting to maintain the patches in position and retard evaporation of the test material. After 24 h the plastic wrappings and gauze patches were removed, and the intact and abraded test sites were scored separately for erythema and edema on a graded scale of 0 to 4; after 72 h, the sites were scored again. The mean primary irritation score (maxi- mum = 8) represents an average of the 24- and 72-h ratings of the intact and abraded sites.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Irritant / corrosive response data:
The substance was determined to be non irritant since the primary irritation score was lower than 5.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was determined to be non irritating to the skin.
Executive summary:

A primary skin irritation test was performed in Albino rabbits. The hair was clipped from the back and flanks of each of 6 rabbits, and two sites located lateral to the midline of the back and approximately 10 cm apart were selected for the test; one site was abraded by making four epidermal incisions, two perpendicular to the other two. A 0.5-ml dose of undiluted test material was applied to each site. The sites were immediately covered with 2-in.-square gauze patches that were secured with masking tape, and the trunk of each animal was wrapped with plastic sheeting to maintain the patches in position and retard evaporation of the test material. After 24 h the plastic wrappings and gauze patches were removed, and the intact and abraded test sites were scored separately for erythema and edema on a graded scale of 0 to 4; after 72 h, the sites were scored again. The mean primary irritation score (maxi- mum = 8) represents an average of the 24- and 72-h ratings of the intact and abraded sites. The mean primary irritation score of the test item was determined to be 0.9 (lower than 5) and thus, it was concluded not be an skin irritant.

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:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
poorly documented
GLP compliance:
no
Specific details on test material used for the study:
Purity of each material was checked in the Organic Chemicals Synthesis Laboratory, AEQI, in Beltsville by gas chromatography: > 98%
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9-3.1 kg
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
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified.
- Time after start of exposure: Not specified.

SCORING SYSTEM: Draize et. al. 1944
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
The eye irritation score was found to be 0.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was determined to be non irritating to the eye.
Executive summary:

The eye-irritating properties were determined by installing a 0.1 ml dose of undiluted sample into the conjunctival sac of the right eye of each of six rabbits; the left eye of each animal served as the control. Grading for eye injury was made at 1, 24, 48 and 72 hr and at 7 days after treatment according to the grading and scoring system of Draize et al. (1944) in which a zero score indicates no irritation and the maximum score at any one scoring period is 110 (maximum irritation and damage to the cornea, iris, and conjunctiva). The mean eye irritation score in rabbits was determined to be 0 and thus, the test item was concluded not to be an eye irritant.

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

Additional information

Justification for classification or non-classification

Based on the available data, the substance is not classified for skin irritation nor eye irritation according to the CLP Regulation (EC) no. 1272/2008.