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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:
From 11 June, 1990 to 14 June, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the Federal guideline: 16 CFR 1500.42.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal guidelines: 16 CFR 1500.42
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cetyltrimethyl ammonium Cl Agent 1403-87-2 5% active
- Physical state: Clear, colourless liquid
- Analytical purity: 5%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet: Pelleted Purina rabbit chow ad libitum
- Water (e.g. ad libitum): Tap water supplied by automatic water system
- Acclimation period: 8 or 45 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-26

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 5%
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: 24, 48 and 72 h

SCORING SYSTEM: Draize score; The eye scores were further classified by the modified system of Kay and Calandra.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
53
Max. score:
110
Reversibility:
not specified
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
59.7
Max. score:
110
Reversibility:
not specified
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 hours
Score:
58.3
Max. score:
110
Reversibility:
not specified
Irritant / corrosive response data:
All treated eyes had corneal opacity, iritis and conjunctival irritation during the 24 to 72 hours test period.
Other effects:
Apart from the eye irritation effects, there were no signs of gross toxicity, adverse pharmacological effects or abnormal behaviour.

Any other information on results incl. tables

See the attached background material:

Table-1: Score for ocular lesions

Table-2: Scale for scoring ocular lesions

Table-3: Classification of eye score

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the scoring system used, the test substance (5% active) was considered to be highly irritating to the eyes.
Executive summary:

A study was performed to assess the potential of C16 TMAC to cause eye irritation in rabbit eyes. 0.1 mL of undiluted test substance (5% active ingredient) was placed in the conjunctival sac of the right or left eye of six rabbits. The other eye of each rabbit remained untreated and served as a control. After instillation of the test substance, ocular lesions were evaluated at 24, 48 and 72 hours according to the Draize method. The eye irritation scores were further classified by the modified method of Kay and Calandra. Based on the scoring system used, the test substance (5% active ingredient) was considered to be highly irritating.