Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 22 February 1988 to 14 March, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to the method equivalent to OECD guideline 405 as well as in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Identification: Quaternary ammonium salt
- Lot No.: 1735305
- Date received: February 10, 1988
- Physical description: Clear yellow liquid
- Storage conditions: Sealed container at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio
- Age at study initiation: Young adult
- Weight at study initiation: 2,634 to 3,104 g at study initiation
- Housing: Individual suspended wire-mesh cages. The animals were maintained in accordance with the recommendations contained in the "guide for care and use of laboratory animals" NIH publication, No. 8502
- Diet: Purina Certified Rabbit Chow #5322
- Water: Tap water
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature : 67-74 °F
- Humidity (%): 40-74%
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From 23 February, 1988 to 8 March, 1988

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
Both eyes were examined at approximately 1, 24, 48 and 72 h after dosing and at 96 h and 7, 14 and 21 d. In addition, both eyes of all rabbits were further examined at 72 h and 7, 14 and 21 d with sodium fluorescein and ultraviolet light.

Number of animals or in vitro replicates:
5 males and 4 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Out of the 9 animals, the eye of the three rabbits were washed with 120 mL of lukewarm tap water for approximately 1 min.
- Time after start of exposure: 30 sec after dosing

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Sodium fluorescein and ultraviolet light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Maximum average score (M.A.S)
Basis:
mean
Time point:
other: 14 d
Score:
96.8
Max. score:
110
Reversibility:
not fully reversible within: 21 d
Remarks on result:
other: This value is for unwashed group
Irritation parameter:
other: Maximum average score
Basis:
mean
Time point:
other: 72 h
Score:
69.7
Max. score:
110
Reversibility:
not fully reversible within: 21 d
Remarks on result:
other: This value is for washed group
Irritation parameter:
other: Maximum average score
Basis:
mean
Time point:
other: 96 h
Score:
69.7
Max. score:
110
Reversibility:
not fully reversible within: 21 d
Remarks on result:
other: This value is for washed group
Irritant / corrosive response data:
The test substance was maximally irritating for the unwashed group and extremely irritating for the washed group.
Other effects:
Purulent discharge, clear discharge, petite hemorrhage, blanching, corneal epithelial damage, corneal neovascularization, sodium fluorescein stain retention.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test substance was classified as Category 1 (irreversible effects on the eye) according EC criteria (67/548/EEC) and CLP criteria (EC 1272/2008).
Executive summary:

A study similar to OECD guideline 405 was conducted to assess the eye irritation potential of C12-C18 TMAC in rabbits. Nine rabbits received 0.1 mL of undiluted solution in one eye. The other eye remained untreated. The eye lids were held close for approximately 1 second after instillation. The eyes of three rabbits were washed for approximately 1minute with 120 mL of lukewarm tap water commencing approximately 30 seconds after dosing. Both eyes were examined at approximately 1, 24, 48 and 72 hours after dosing and at 96 hours and 7, 14 and 21 days. In addition, both eyes of all rabbits were further examined at 72 hours and 7, 14 and 21 days with sodium fluorescein and ultraviolet light. The maximum average score for the test substance were calculated to be 96.8 on Day 14 for the washed group and 69.7 at both 72 and 96 h for the washed group. Under the test conditions, C12-C18 TMAC was considered to cause irreversible effects on the eye (Nass DJ, 1988).