Benzenesulfonic acid, mono-C10-13-alkyl derivs., potassium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 24, 1986 to 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

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

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

Cas Number:

68411-30-3

IUPAC Name:

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

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Purity/Activity: 47%
Average alkyl chain length = C11.2
Appearance: clear yellow liquid stored at ambient temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

For three rabbits the eyelids were then gently held together for 1 sec before releasing (study 1). For three other rabbits the eyes were irrigated with water for 5 min following a 4-sec exposure (study 2). For the remaining three rabbits the eyes were irrigated for 5 min following a 30-sec exposure (study 3).

Observation period (in vivo):

Eyes were examined after 1 h and 1, 2, 3, 4, 7, 14 and 21 d 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:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

1.75

Max. score:

4

Reversibility:

not fully reversible within: 21 d

Remarks on result:

other: study 1

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: study 2

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

1.06

Max. score:

2

Reversibility:

fully reversible within: 14 d

Remarks on result:

other: study 3

Irritant / corrosive response data:

The following results were noted:
1) Three animals without any rinsing: averaged irritation scores (24/48/72 h) 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 5 min following a 30 sec 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 d after instillation.
3) Three animals with rinsing for 5 min following a 4 sec 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 d after instillation.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under the study conditions, the substance induced irreversible effects in the rabbit eye and is considered to be serious eye damaging.

Executive summary:

A study was conducted to determine the eye irritation potential of the substance

according to OECD Guideline 405, in compliance with GLP. A set of three studies were performed. 0.1 mL of the undiluted test substance was placed into the eyes of groups of three rabbits. In one group, the eyes were not rinsed. In the second group, the eyes were rinsed after 4 sec of exposure and in the third group, the eyes were rinsed after 30 sec of exposure. Observations were made at 1 h and 1, 2, 3, 4, 7, 14, and 21 d 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 d. Irritation was also seen in the animals rinsed after 30 sec, although the irritation was not as severe, and the effects were fully reversible within 14 d. Mild irritation was seen in the animals rinsed after 4 sec. These effects were fully reversible within 7 d. Under the study conditions, the substance was considered to be damaging to eyes (Liggett, 1986b).