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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
Study period:
29.01.-12.02.1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
α-acetyl-γ-butyrolactone
EC Number:
208-235-2
EC Name:
α-acetyl-γ-butyrolactone
Cas Number:
517-23-7
Molecular formula:
C6H8O3
IUPAC Name:
α-acetyl-γ-butyrolactone

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
no data
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
14 d
Score:
3.25
Reversibility:
fully reversible
Other effects:
Generally slight diffuse corneal opacity was observed in the animals nos. 67 (male) and 68 (female) from 1 to 48 hours after treatment. Generally slight diffuse corneal opacity was observed in the animal no. 69 (female) at 1 to 72 hours. At day 7 slightly spotted diffuse corneal opacity was observed in the
same animal only.

Any other information on results incl. tables

no other remarks

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the conditions of this experiment, A-LACTON was found to cause a primary irritation score of: 3.25, when applied to the conjunctival sac of the rabbit eye.
Executive summary:

Under the conditions of this experiment, A-LACTON was found to cause a primary irritation score of: 3.25, when applied to the conjunctival sac of the rabbit eye.

Generally slight diffuse corneal opacity was observed in the animals nos. 67 (male) and 68 (female) from 1 to 48 hours after treatment. Generally slight diffuse corneal opacity was observed in the animal no. 69 (female) at 1 to 72 hours. At day 7 slightly spotted diffuse corneal opacity was observed in the same animal only.