Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with ethanolamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 24, 1986-May 12, 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

EC Number:

270-115-0

EC Name:

Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts

Cas Number:

68411-30-3

Molecular formula:

LAS is the sodium salt of linear alkylbenzene sulfonic acid with alkyl carbon chain lengths ranging from C10 to C13 and averaging 11.6. The primary structure is a C10 to C13 linear alkyl chain with a para-substituted benzene sulfonic acid sodium salt group attached at any of the secondary alkyl carbon positions

IUPAC Name:

sodium 4-undecylbenzenesulfonate

Test material form:

liquid

Details on test material:

- Name of test material: Alkylbenzene sulfonate, sodium salt (designated as P-500 N-Na)
- Activity: 47%.
- Average alkyl chain length: C11.2.
- Physical state: Clear yellow liquid, stored at ambient temperature.

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield Rabbits and Buckmasters
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2.1-3.1 kg
- Housing: individually housed in metal cages, identified by aluminum ear tags
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation: yes


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 degree C
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

IN-LIFE DATES: From: March 24, 1986 To: May 12, 1986

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 mL aliquot of P-500 N-Na

Duration of treatment / exposure:

For three rabbits the eyelids were then gently held together for one second before releasing.
For three other rabbits the eyes were irrigated with water for 5 minutes following a 4-second exposure.
For the remaining three rabbits the eyes were irrigated for 5 minutes following a 30-second exposure.

Observation period (in vivo):

Eyes were examined after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after exposure.

Number of animals or in vitro replicates:

9

Details on study design:

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

not reversible

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The following results were noted:
1) Three animals without any rinsing:  averaged irritation scores (24, 48, 72 hours) for each animal: cornea 2.3, 1.7, 2; iris: 1.3, 0, 0; conjunctivae redness: 3, 1.7, 2; conjunctivae chemosis: 3, 2, 2.  In the first animal the effects were persistent at day 21.
2) Three animals with rinsing for five minutes following a 30 second exposure: averaged scores: cornea 0.7, 1, 1.3; iris: 0, 0.7, 0.3; conjunctivae redness: 1.7, 2, 1.3; conjunctivae chemosis: 2, 1.3, 2.  The eyes were normal 7 or 14 days after instillation.
3) Three animals with rinsing for five minutes following a 4 second exposure: averaged scores: cornea 0.7, 2.3, 0.7; iris: 0, 0, 0; conjunctivae redness: 1.7, 1.7, 1; conjunctivae chemosis: 1.3, 2, 1.  The eyes were normal 7 days after instillation.

Findings lead to a definition of irritating for LAS at 47% applied without rinsing, irritating (even if with lower effects, mainly as cornea opacity and conjunctivae redness) with rinsing after 30 second of exposure, and not irritating with rinsing after 4 second of exposure.

Any other information on results incl. tables

Results of Eye Irritation Study – No Rinsing

		Hours				Days
Animal		1	24	48	72	4	7	14	21
1	Cornea	2	1	2	4	3B	3B	3BC	3BC
	Iris	0	1	1	2	1	1	1	0
	Conjunctiva - Erythema	1	3	3	3	3	3	2	1
	Conjunctiva – Chemosis	2	3	3	3	3	2	2	1
2	Cornea	1	1	2	2	2	1	0
	Iris	0	0	0	0	0	0	0
	Conjunctiva - Erythema	1	1	2	2	1	0	0
	Conjunctiva – Chemosis	1	2	2	2	1	0	0
3	Cornea	1	2	2	2	2	1	0
	Iris	0	0	0	0	1	0	0
	Conjunctiva - Erythema	1	2	2	2	2	1	0
	Conjunctiva – Chemosis	1	2	2	2	2	0	0

Results of Eye Irritation Study – Rinsing after 4 Seconds

		Hours				Days
Animal		1	24	48	72	4	7
1	Cornea	0	0	1	1	1	0
	Iris	0	0	0	0	1	0
	Conjunctiva - Erythema	1	2	2	1	2	0
	Conjunctiva – Chemosis	2	2	1	1	1	0
2	Cornea	0	2	3	2	0	0
	Iris	0	0	0	0	0	0
	Conjunctiva - Erythema	1	2	2	1	2	0
	Conjunctiva – Chemosis	2	2	2	1	1	0
3	Cornea	0	1	0	1	1	0
	Iris	0	0	0	0	0	0
	Conjunctiva - Erythema	1	1	1	1	2	0
	Conjunctiva – Chemosis	2	1	1	1	1	0

Results of Eye Irritation Study – Rinsing after 30 Seconds

		Hours				Days
Animal		1	24	48	72	4	7	14
1	Cornea	0	1	0	D	D	1	0
	Iris	0	0	0	0	0	0	0
	Conjunctiva - Erythema	1	2	2	1	1	1	0
	Conjunctiva – Chemosis	2	1	1	0	0	0	0
2	Cornea	0	1	1	1	2	0
	Iris	0	0	1	1	0	0
	Conjunctiva - Erythema	1	2	2	2	2	0
	Conjunctiva – Chemosis	2	1	2	1	1	0
3	Cornea	0	1	2	1	2A	2AB	0
	Iris	0	0	0	1	1	1	0
	Conjunctiva - Erythema	1	1	1	2	2	2	0
	Conjunctiva – Chemosis	2	2	2	2	1	1	0

A – Loss of Corneal Epithelium

B – Vascularization

C – Pannus

D – Dulling of the Cornea

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

When not rinsed, damage to the eyes due to the test substance was not reversed within 21 days. According to EU GHS guidelines the test substance is a category 1 eye irritant.

Executive summary:

This study examined the potential of the test substance to cause irritation to eyes. Groups of three rabbits had 0.1 ml of test substance placed in each of their eyes. In one group, the eyes were not rinsed. In the second group, the eyes were rinsed after 4 seconds of exposure. In the third group, the eyes were rinsed after 30 seconds of exposure. Observations were made one hour and 1, 2, 3, 4, 7, 14, and 21 days after exposure. Severe irritation was noted in the animals whose eyes were not rinsed. This irritation was not resolved in one of these animals at the end of 21 days. Irritation was also seen in the animals rinsed after 30 seconds, although the irritation was not as severe, and the effects were fully reversible within 14 days. Mild irritation was seen in the animals rinsed after 4 seconds. These effects were fully reversible within 7 days. Since OECD guideline 405 for eye irritation studies calls for an exposure of at least 24 hrs, the results for unrinsed eyes were used for classification. According to these results, the test substance is a category 1 eye irritant because it caused damage that was not reversible within 21 days.