Benzoic acid, C12-15-alkyl esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 October 1978 to 31 October 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid, C12-15-alkyl esters

EC Number:

270-112-4

EC Name:

Benzoic acid, C12-15-alkyl esters

Cas Number:

68411-27-8

Molecular formula:

C19-22 H30-36 O2

IUPAC Name:

Benzoic acid, C12-15-alkyl esters

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey, USA
- Diet: Wayne animal feed, ad libitum
- Water: ad libitum
- Acclimation period: conditioned prior to use

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye, remaining untreated, of each rabbit served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml, singe administration
- Concentration (if solution): undiluted, test material as received

Duration of treatment / exposure:

24 h ( no wash)

Observation period (in vivo):

1, 2, and 3 days after treatment, and up to 7 days when necessary

Number of animals or in vitro replicates:

6 (mixed sex), 1.8 - 2.4 kg

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The trated eyes remained unwashed for 24 hours


SCORING SYSTEM: Draize standard scoring system:
Cornea Opacity (A) Grading 0-4
Area of Cornea Involved (B) Grading 0-4
Score equals A x B x 5 Total maximum = 80

Iris Values (A) Grading 0-2
Score equals A x 5 Total maximum = 10

Conjunctivae Redness (A) Grading 0-3
Chemosis (B) Grading 0-4
Discharge (C) Grading 0-3
Score equals (A + B + C) x 2 Total maximum = 20

Note: The maximum total score is the sum of all scores obtained for the cornea, iris and conjunctivae.

TOOL USED TO ASSESS SCORE: hand-held lenses

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

chemosis score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

Result: Draize Score
______________Day_________________
Group 1 2 3 4---------7
_______________________________________________
No Wash 0.0 0.0 0.0 --- ---

The test substance is not an ocular irritant to rabbits under the conditions of the test.

Any other information on results incl. tables

   

Rabbit Number	Day	Cornea: A x B x 5 +	Iris: A x 5 +	Conjunctivae: (A+B+C) x 2=	Total Scores*
1, 2, 3, 4, 5, 6	1	0   0	0	0  0  0	0
1, 2, 3, 4, 5, 6	2	0   0	0	0  0  0	0
1, 2, 3, 4, 5, 6	3	0   0	0	0  0  0	0
1, 2, 3, 4, 5, 6	4	-   -	-	-  -  -	-
1, 2, 3, 4, 5, 6	7	-   -	-	-  -  -	-
Average	1				0.0
	2				0.0
	3				0.0
	4				-
	7				-

* Total score possible/animal/observation interval = 110

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is not an ocular irritant to rabbits under the conditions of the test.

Executive summary:

The test substance was tested in an eye irritation study. Six New Zealand rabbits, mixed sex, 1.8 - 2.4 kg, received 0.1 ml test substance (material used as received) in a single administration instilled in the right eye; the left eye, remaining untreated, served as control. The treated eyes of all rabbits remained unwashed for 24 hours. Observations of injuries on the cornea, iris and the bulbar and palpebral conjunctivae were made 1, 2, and 3 days after treatment; further readings were not necessary. Numerical scores were assigned according to the Draize standard scoring system.

Result:                                           Draize Score

_________Day____________

Group 1 2 3 4-------7

No Wash 0.0 0.0 0.0 -- --

The test substance is not an ocular irritant to rabbits under the conditions of the performed test.