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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Remarks:
in vitro
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The information is provided from a reliable secondary source.

Data source

Reference
Reference Type:
other: secondary source
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 42
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
- the original study was conducted in 1975

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Appearance: Blue powder
- Name of test material (as cited in study report): Sanolin Blue EHRL
- Other name(s): C.I. Acid Blue 182
- Marketing names: Sanolin Blue E-HRL, Sandolan Blue E-HRL 180, Sandolan Blue E-HRL, Alizarinlichtblau HRL
- Degree of purity: High

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No data
Duration of treatment / exposure:
No data
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
Ocular reactions were scored using the Draize method. Eyes were evaluated at 24, 48 and 72 hours and animals continued to be observed for the remainder of the 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: Mean at 24, 48 and 72 hours
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: Mean at 24, 48 and 72 hours
Score:
0.05
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: Mean at 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: Mean at 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: Mean at 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
Redness of the conjunctiva was observed in 3 animals, which persisted up to 7 days in 2 animals. Chemosis was seen in 1 animal, which resolved by 48 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test material is non-irritating to the eye.
Executive summary:

The eye irritation potential of the test material was investigated in accordance with the standard methods prescribed by the Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 42. These methods are similar to those outlined in the standardised guideline OECD 405.

Six Albino rabbits were exposed to the test material and observed for 7 days. Ocular reactions were scored using the Draize method. Eyes were evaluated at 24, 48 and 72 hours and animals continued to be observed for the remainder of the 7 days.

Redness of the conjunctiva was observed in 3 animals, which persisted up to 7 days in 2 animals. Chemosis was seen in 1 animal, which resolved by 48 hours.

Under the conditions of this study, the test material is non-irritating to the eye.