Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only one animal

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Only one animal
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Pluriol A 308 R, But-2-in-1,4-diol, ethoxylated
batch 09/99

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Details on study design:
The principle application regimen was in accordance with the OECD guideline 404. The test substance was applied undiluted. Readings were performed 1, 24, 48 and 72h following application of the test substance.

Results and discussion

Any other information on results incl. tables

1h following application of the test substance mild redness and slight chemosis of the conjunctiva was observed. Additionally slight discharge was observed. No indications for corneal opacity or iris effect. All findings were reversible until 24h after application of the test substance.

Accordingly the test substance is not irritating to the eyes under the conditions of the test.

Applicant's summary and conclusion