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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:
1986-01-07 to 1986-01-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1981)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
2,2,4(or 2,4,4)-Trimethylhexanedioic acid of Hüls AG, purity 87 %, impurities methylpentanedoic acid and methylbutanedioic acid not quantified

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: female
- Weight at study initiation: 2.8 kg
- Controls: untreated eye- Housing: single housing
- Diet: ad libitum, special diet for rabbits, SSniff K4
- Water: ad libitum, tab water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 +/- 1 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: identical animals, left eyes remained untreated
Amount / concentration applied:
Amount applied: 0.1 ml undiluted
Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
1
Details on study design:
ADMINISTRATION/EXPOSURE 
- Preparation of test substance: heating (melting) in water bath,  treatment at 40 °C
- Vehicle: none
- rinsed after 72 hours
- Postexposure observation period: 3 days
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Tool used to assess score: visual inspections, no tools required
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1.33
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 4.0
- Iris: assessment impossible due to opaqueness of cornea
- Conjunctivae (Redness): 3.0
- Conjunctivae (Chemosis): 1.33
- Overall irritation score: not calculated
DESCRIPTION OF LESIONS: 
- immediately: opalescence of cornea, pupil and iris hardly to be seen
- 15 minutes after treatment: cornea milky, pupil and iris not to be  seen, severe corrosion of conjunctival sac, nictitating membrane, and  conjunctiva
REVERSIBILITY: not reversible
Other effects:
head held skewed immediately after treatment

Any other information on results incl. tables

Because of strong irritant effects only one animal was used and study was broken off after 72 hours.

iris score (animal no. 1): assessment impossible due to opaqueness of cornea



Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize (1959); Appendix VI of 79/831/EEC
Conclusions:
Classification: risk of serious damage to eyes
Executive summary:

2,2,4(or 2,4,4)-Trimethylhexanedioic acid was investigated for irritant effects on the eye and associated mucous membranes of 1 female rabbit according to OECD TG 405 (1981). The test substance was applied in a single dose of 0.1 ml into the conjuntival sac of the animal. Immediately after application opalescence of cornea appeared, pupil and iris were hardly to be seen, head was held skewed. 15 minutes after treatment the cornea was milky, pupil and iris were not to be seen, severe corrosion of conjunctival sac, nictitating membrane and conjunctiva were observed. The lesions were not reversible. Therefore 2,2,4(or 2,4,4)-trimethylhexanedioic acid must be classified as corrosive.