Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2003-01-27 to 2003-02-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

92/69/EEC

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

August 1998

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: MAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-860-6

EC Name:

-

Cas Number:

302776-68-7

Molecular formula:

C24 H31 N O4

IUPAC Name:

hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain / quality: New Zealand White A1077 INRA (SPF)
- Sex: males and females
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 3 months
- Weight at study initiation: 2.30 - 2.61 kg
- Housing: Single housing. The animals were housed in fully air-conditioned rooms.
Stainless steel wire mesh cages with grating, floor area: 3000 cm2.
- Diet (e.g. ad libitum): Kliba laboratory diet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days before beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2003-01-27 (first application) To: 2003-02-06

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: one eye of each animal was left untreated

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (undiluted)
- Temperature of the substance when volume to be applied is measured: 60°C
- Temperature of the substance when applied to eye: Cooled down to body temperature

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with tap water
- Time after start of exposure: 24 h

SCORING SYSTEM:
According to the quoted guidelines. In addition to specific observations recommended by regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.

Area of cornea involved (ar):*
1 = >0; <=1/4
2 = >1/4; <1/2
3 = >1/2; <3/4
4 = >3/4
* The assessment of these ocular reactions is performed independently of the quoted guidelines.

Discharge (di):*
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye
* The assessment of these ocular reactions is performed independently of the quoted guidelines.

Description of any ocular findings not covered by this scale was recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24,48,72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24,48,72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24,48,72 h

Score:

0

Max. score:

2

Results 8

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24,48,72 h

Score:

0

Max. score:

2

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 24,48,72 h

Score:

0

Max. score:

3

Results 10

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: 24,48,72 h

Score:

0

Max. score:

3

Results 11

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: 24,48,72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Results 12

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible

Results 13

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 14

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 15

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Results 16

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24,48,72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Mean scores calculated for all animals over 24, 48 and 72 hours were 0.0 for corneal opacity, iris lesions, chemosis, and discharge. The respective mean value for redness was 0.1.
Mean scores calculated individually for each animal over 24, 48 and 72 hours were always 0.0 for corneal opacity, iris lesions, chemosis, and discharge and redness, except for one animal for which a mean value for redness of 0.3 was recorded.

Other effects:

no other effects observed

Any other information on results incl. tables

Readings	Animal	Cornea		Iris	Conjunctiva			Additional findings
		Opacity	Area of cornea involved		Redness	Chemosis	Discharge	-
1h	01	0	0	0	1	0	1	-
	02	0	0	0	2	0	1	-
	03	0	0	0	2	0	2	-
24 h	01	0	0	0	0	0	0	-
	02	0	0	0	0	0	0	-
	03	0	0	0	1	0	0	-
48 h	01	0	0	0	0	0	0	-
	02	0	0	0	0	0	0	-
	03	0	0	0	0	0	0	-
72 h	01	0	0	0	0	0	0	-
	02	0	0	0	0	0	0	-
	03	0	0	0	0	0	0	-
Mean	01	0.0	-	0.0	0.0	0.0	-	-
	02	0.0	-	0.0	0.0	0.0	-	-
	03	0.0	-	0.0	0.3	0.0	-	-
Mean	-	0.0	-	0.0	0.1	0.0	-	-

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

According to the conditions of the test, the test substance has not to be classified as irritating to the eye following EU and the GHS requirements.