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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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline studies with acceptable restrictions

Data source

Reference
Reference Type:
other:
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.36 +/- 0.41 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Animals were held in isolated animal rooms with filtered air suply, temperature and humidity control
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
Group 1: 24 hrs
Group 2: 15 seconds
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
Group 1: 6 animals; 24 hrs
Group 2: 3 animals; 15 seconds
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Group 2
- Time after start of exposure: 15 seconds

SCORING SYSTEM: Draize (1959); table contained in OECD 405

TOOL USED TO ASSESS SCORE: biomicroscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: day 13
Score:
13.3
Max. score:
80
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: unwashed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 13 days
Score:
0
Max. score:
10
Reversibility:
other: iris was not affected at any reading
Remarks on result:
other: unwashed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 13 days
Score:
7.3
Max. score:
20
Reversibility:
other: redness persisted (score: 1) on day 13 whereas chemosis and discharge were fully reversible. Corneal opacity was not reversible.
Remarks on result:
other: unwashed eyes

Applicant's summary and conclusion

Executive summary:

N,N-dimethylbutylamine was considered to be a severe eye irritant, based on the results of a study that was conducted essentially similar to OECD 405. The eye reactions of rabbits were recorded up to 14 days after the application of 0.1 mL of the test substance into the conjunctival sac of rabbits, either for 24 hours (Group 1, 6 animals) or 15 seconds (Group 2, 3 animals; eye washed with water). The eye reactions of Group 1 animals indicated marked reactions of the cornea and conjunctivae, whereas the iris was not affected. The conjunctival reactions were largely reversible by day 13, whereas the corneal lesions persisted until the end of the observation period. (Cox and Botta, 1979).

 

The study is considered to be valid with minor restrictions.