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:
key study
Study period:
10 Feb - 28 Mar 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted Oct 2012
Deviations:
yes
Remarks:
no topical anesthetics and systemic analgesics were used; no initial test was performed
GLP compliance:
no

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
- Source: Nihon Dobutsu Co., Osaka, Japan
- Weight at study initiation: 2.35 - 2.68 kg
- Diet: CG-3 type (Clea Japan Inc., Osaka, Japan), 100 g/day
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2
- Humidity (%): 60 ± 10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
Group 1: Single application without washing
Group 2: 30 s
Observation period (in vivo):
1, 24, 48, 72 and 96 h and 7 days
Number of animals or in vitro replicates:
6 (Group 1) and 3 (Group 2)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes of the animals in Group 2 were rinsed with lukewarm water
- Time after start of exposure: 30 s (Group 2); the treated eye remained unwashed following the instillation (Group 1)

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: unwashed
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: unwashed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: unwashed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: washed
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: washed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: washed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: washed
Irritant / corrosive response data:
All animals showed no conjunctival redness and swelling resulting in a mean score of 0 for both endpoints over 24, 48 and 72 h, respectively. The cornea opacity and iris score were also graded with scores of 0 over 24, 48 and 72 h, respectively.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008.
Conclusions:
CLP: not classified