Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo study that was performed prior to current requirement for in vitro alternative testing
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: older study; not conducted in accordance with current GLP guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24 hours
Number of animals or in vitro replicates:
3
Details on study design:
Eye irritation studies in the Kodak laboratory were conducted using a method similar to that described in the current OECD Guideline. However, the test material was administered to six, rather than three, rabbit eyes. Three of the eyes were subsequently washed, so the effect of washing on the subsequent development of irritant responses could be evaluated. The effect of washing is not evaluated in current Guideline studies.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Irritation, limited to erythema of the adnexa, resolved after one hour. No adnexal or corneal staining was observed. Immediate washing was beneficial.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based upon the findings of this study, p-diisopropylbenzene is slightly irritating to the eyes of rabbits.
Executive summary:

A 0.1 mL aliquot of p-diisopropylbenzene was instilled into both eyes of 3 rabbits; in one eye of each rabbit, the material was immediately rinsed with water, while in the other eye, the material remained without washing. Immediately after instillation, slight erythema was observed in 3 of 3 rabbits that was limited to the adnexa, and washing was palliative. At one hour after instillation, all signs of irritation had resolved in all rabbits.