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Toxicological information

Eye irritation

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Administrative data

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: No description of GLP compliance is availabile.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: U.S. Federal Hazardous Substances Labeling Act, CFR 1500.42 Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, September 1973
Deviations:
no
Principles of method if other than guideline:
U.S. Federal Hazardous Substances Labeling Act, CFR 1500.42 Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, September 1973
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isooctyl acrylate
EC Number:
249-707-8
EC Name:
Isooctyl acrylate
Cas Number:
29590-42-9
Molecular formula:
C11H20O2
IUPAC Name:
6-methylheptyl acrylate
Constituent 2
Reference substance name:
T-1746IE
IUPAC Name:
T-1746IE
Details on test material:
- Name of test material (as cited in study report: T-1746IE

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Age at study initiation: Young adults

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
0.1 ml of the test material was instilled into the right eyes and was not washed from the eyes
Observation period (in vivo):
1, 24, 48, 72 hours and 5 and 7 days
Number of animals or in vitro replicates:
6 animals per dose
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
- Time after start of exposure: First observation at 1 hour after exposure
SCORING SYSTEM: Draize scoring
TOOL USED TO ASSESS SCORE: Not described

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
fully reversible
Remarks on result:
other: The mean primary irritation scores at examinations: 1h: 1/8, 24h: 0/8, 48h: 0/8, 72h: 0/8, 7d: 0/8
Remarks:
All animals (6/6) exhibited discharge at 1-hour (scores of 1), and 4/6 animals exhibited mild chemosis (scores of 1) at 1 hour. No irritation was observed at any other time point.
Irritant / corrosive response data:
Test material was determined not to be a primary ocular irritant.

Any other information on results incl. tables

72 -hours score : 0.0 -8.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
Conclusions:
The test material was not a primary ocular irritant based on test conditions.
Executive summary:

Undiluted test material (0.1 ml) was instilled into the right eyes of six young adult albino rabbits. The test material was not washed from the eyes. Contralateral eyes were used as controls. Eyes were examined at 1, 24, 48, 72 hours and 5 and 7 days and scored (Draize method). The mean primary irritation scores at examinations: 1-hour (1.0/8.0); 24 hours (0.0/8.0); 48 hours (0.0/8.0); 72 hours (0.0/8.0); 5 days (0.0/8.0); and 7 days (0.0/8.0). At 1-hour, all animals exhibited a slight discharge and four of the animals had slight chemosis. No evidence of irritation was noted at any other examination time. The test material was concluded not to be a primary ocular irritant.