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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:
From 12 to 26 march 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Poory details

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: single application of 0.1 ml (76.6 mg)
Duration of treatment / exposure:
Single application
Observation period (in vivo):
1, 24, 48 amd 72 hours and 7 days after administration
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal: All rabbits (65967, 66032 and 66033 males)
Time point:
other: 1, 24, 48, 72 hours and 7 days
Score:
ca. 10
Reversibility:
fully reversible
Irritant / corrosive response data:
The test material produced moderate conjunctival irritation.
Dark red-coloured staining of the lower conjunctival and nictitating membranes and red-coloured staining of the fur around the treated eye were also noted. One treated eye appeared normal at the 72-hour observation and the two remaining treated eyes appeared normal atthe 7-day observation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: MILD IRRITANT (CLASS 4 ON A 1-8 SCALE)
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.
Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.09), The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 405 "Acute Eye Initation/Corrosion" and Method B5 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 67/548/EEC).

Classification: MILD IRRITANT (CLASS 4 ON A 1-8 SCALE). The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC