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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:
1986-06-24 to 1986-07-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was performed according to OECD guideline 405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5,5-trimethylhexanoic acid
EC Number:
221-975-0
EC Name:
3,5,5-trimethylhexanoic acid
Cas Number:
3302-10-1
Molecular formula:
C9H18O2
IUPAC Name:
3,5,5-trimethylhexanoic acid
Test material form:
liquid
Details on test material:
Name of test material (as cited in study report): Isononansäure

Charge 1144 from 1985-11-19, not specified isomer mixture, purity 99,7% with 0.25-0.3% main impurities

Test animals / tissue source

Species:
rabbit
Strain:
other: Small White Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 1.97-2.1 kg
- Housing: individual in cages
- Diet: K4 Alleindiät für Kaninchen, Ssniff Spezialfutter, Soest, Germany, ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 60 +/- 5
- Air changes (per hr): 15-fold
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
72 h
Observation period (in vivo):
1, 24, 48 and 72 h as well as 6, 8, 10, 13, 17 and 21 days post application
Number of animals or in vitro replicates:
3 males
Details on study design:
0.1 ml of the test substance was applied into the conjunctival sac of one eye of each animal, the other eye served as control. The exposed eye was treated with fluorescein solution to detect cornea damage and afterwards rinsed with warm physiological saline.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h - 21 days
Score:
41.84
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.78
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: individual scores (24-48-72 h): 2.0, 1.67, 1.67, calculated from the data in the attached document
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: individual scores (24-48-72 h): 1.0, 1.0, 1.0, calculated from the data in the attached document
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: individual scores (24-48-72 h): 3.0, 3.0, 3.0, calculated from the data in the attached document
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: individual scores (24-48-72 h): 1.0, 1.0, 1.0, calculated from the data in the attached document

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test substance was irritating to the eye. As lesions were still persisting at the end of the observation period, the results have to be considered as "severely irritating to the eye".
Executive summary:

Effects on eyes have been assessed in a test according to OECD TG 405. The application of undiluted test substance to the eyes of rabbits produced an eye irritation to be considered as severe (effects still present at the end of the observation time; overall irritation score: 41.48/110, cornea score:1.78/4, iris score: 1/2, conjunctivae score: 3.0/3, chemosis score: 1.0/4) (Hüls AG, 1986).

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