Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 405: GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
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
- Source: Kleintierfarm Madoerin AG
- Age at study initiation: ca. 14-15 weeks
- Weight at study initiation: 2.9-2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, batch 34/88 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days under laboratory conditions after veterinary examination


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of each animal (the right eye) served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
Duration of treatment / exposure:
The test material was instilled into the lower conjunctival sac of the left eye of each animal. The upper and lower lids were gently held together for approximately 1 second to prevent loss of the material. The right eye remained untreated and served as the reference control.
Observation period (in vivo):
The eyes of each animal were examined 1, 24, 48, and 72 hours after administration. The irritation was assessed according to the OECD guidelines for testing of chemicals, section 4, number 405 "Acute eye irritation/corrosion" adopted February 24, 1987.
Number of animals or in vitro replicates:
3 males, 3 females
Details on study design:
SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 hour
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 hour
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 hour
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for MRD-91-972 were all 0. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

C9-C11, cyclic aliphatics was administered to the left eye of three male and three female rabbits to assess for ocular irritation. Ocular examinations occurred at 1h, 24h, 48h, 72h. Ocular damage was assessed and scored according to the Draize eye test. All animals survived the exposure. The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for C9-C11, cyclic aliphatics were 0, 0, 0, and 0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.