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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethyloctane-1,7-diol
EC Number:
203-517-1
EC Name:
3,7-dimethyloctane-1,7-diol
Cas Number:
107-74-4
Molecular formula:
C10H22O2
IUPAC Name:
3,7-dimethyloctane-1,7-diol
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: DR . K . THOMAE GMBH, BIBERACH, FRG
- Age at study initiation: YOUNG ADULT ANIMALS
- Weight at study initiation: 3.00-3.38 kg
- Housing: single housing
- Diet (e.g. ad libitum): ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Water (e.g. ad libitum): KLIBA-LABORDIAET 341, KLINGENTALMUEHLE AG, KAISERAUGST, SWITZERLAND, (ABOUT 130 G PER ANIMAL PER DAY)
- Acclimatization period: at least 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: negative control: untreated eye
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
24 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1/24/48/72h and 8 d
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1/24/48/72h and 8d
Score:
0.2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 1/24/48/72 h and 8 d
Score:
2.1
Max. score:
3
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Due reversible of conjunctivae redness (score >=2) a classification of Category 2B is justified.
Executive summary:

Three White New Zealand were subject to a single ocular application of 0.1 mL. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d.