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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 28 JUL 1992 to 31 JUL 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EPA-TSCA 40 CFR 798
Deviations:
no
Principles of method if other than guideline:
- test for acute irritation of the eye in rabbits (0.1 mL of the test item was instilled into the conjunctival sac of one eye of each rabbit (6 animals in total). The eyes remained unwashed. Ocular responses were assessed at 1 hour post dose and on days 1, 2 and 3.)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- 3 male /3 female animals tested
- Source: Ace animals
- Weight at study initiation: 2.4 to 2.9 kg
- Housing: 1/ cage in suspended
- Diet: Fresh purina rabbit chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light):12 /12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
72 h (eyes remained unwashed)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6 (3 males/3 females)
Details on study design:
SCORING SYSTEM: basically in accordance to OECD TG 405
- evaluation was performed 1, 24, 48, and 72 hours after application of the test item
TOOL USED TO ASSESS SCORE: The eyes of all rabbits were examined with sodium fluorescein after the 24 hour reading.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1/#2/#3/#4/#6
Time point:
other: 24-48-72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritant / corrosive response data:
- there were no corneal or iridial effects, as well as no chemosis visible at any time
- in 1/6 animals there was a conjunctival effect visible (score (redness):1) at the 24 hour reading. At any other time as well as in the remaining animals no conjunctival effects were observed.
Other effects:
For up to one hour after the instillation of the test item into one eye it remained in the conjunctiva in all animals as well as the area around the eyes were stained magenta for the whole duration of the test.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material 2, 9-Dichloroquinacridone is not irritating to eyes under these test conditions. Test material 2, 9-Dichloroquinacridone contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material 2, 9-Dichloroquinacridone was subject to an acute eye irritation/corrosion test in 6 New Zealand white rabbits according to FDA guideline. The test item (0.1 mL) was instilled into the conjunctival sac of one eye of each rabbit and the eyes remained unwashed. Ocular responses were assessed at 1 hour post dose and on days 1, 2 and 3. Under these conditions no corneal or iridial effects were observed. Chemosis was not found likewise. Conjunctival redness was observed in 1/6 animals at 24 hours after instillation of the test item (score (redness): 1). This effect was fully reversible by 48 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material 2, 9 -Dichloroquinacridone is not irritating to eyes and has not to be classified for eye irritation.