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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
OECD TG 405
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
The in vivo eye irritation test was performed before the Reach regulation enforced in vitro testing

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

1
Chemical structure
Reference substance name:
2-tert-pentylcyclohexyl acetate
EC Number:
267-500-0
EC Name:
2-tert-pentylcyclohexyl acetate
Cas Number:
67874-72-0
Molecular formula:
C13H24O2
IUPAC Name:
2-tert-pentylcyclohexyl acetate

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left eye
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the substance was not removed

SCORING SYSTEM: Scorings were recorded on day 1, 2, 3, 4, and 7 according to the Draize scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, and #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Instillation of the test material as described produced a definite conjunctival irritation in all three treated eyes. On the seventh day of observation the treated eyes were normal.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Remarks:
according to CLP (EC 1272/2008 and its updates)
Conclusions:
The substance is considered irritating to the eyes.
Executive summary:

In a pre-GLP acute toxicity study similar to OECD 405, 0.1 mL neat test material was installed in the right eye of 3 albino rabbits. The left untreated eye served as control. The eyes were examined 24, 48, 72 hours and 7 days after instillation of the test substance and scored according to the Draize scale. No corneal opacity or iris congestion was observed. Redness and chemosis were observed in all animals, but the effects were reversible in all animals within 7 days. Mean 24, 48 and 72 hour redness was 1.33 in one animal and 2 in two animals. Therefore, the test substance was considered irritating to eyes.