Dodecylbenzenesulphonic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

Conducted study is in vivo and was conducted prior to the requirement for in vitro studies and before these asays were perfected for use

Type of information:

experimental study

Remarks:

the tested substance is AMP one of the components of the compound

Adequacy of study:

key study

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study appears to have been conducted in accordance to a standard protocol (at the time) for assessing the eye irritation potential of compounds. Although there is limited information on the methods used the reporting is sufficient to come to a conclusion on the endpoint.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

Draize technique (Draize, J.H., Woodard, G. & Calvery, H.O. (1944) Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. and Exp. Therapeutics. 82, 377–390.)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-2-methylpropanol

EC Number:

204-709-8

EC Name:

2-amino-2-methylpropanol

Cas Number:

124-68-5

Molecular formula:

C4H11NO

IUPAC Name:

2-amino-2-methylpropan-1-ol

Details on test material:

AMP regular was tested. No details on purityAMP-regular typically contains approx 98% AMP

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No details given

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml undiluted

Duration of treatment / exposure:

Animals were dosed with the test material, in one study the eyes were flushed 15-30 seconds after application, and in the other, they were not. No further methods information was given.

Observation period (in vivo):

scoring of results took place at 24 and 48 hours after exposure only. No further information on any subsequent observation period.

Number of animals or in vitro replicates:

6 animals in each study

Details on study design:

No additional Information

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48h

Score:

110

Max. score:

110

Reversibility:

not specified

Remarks on result:

other: un flushed eyes

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48h

Score:

69.3

Max. score:

110

Reversibility:

not specified

Remarks on result:

other: eye flushed after 15 seconds

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48h

Score:

89.3

Max. score:

110

Reversibility:

not specified

Remarks on result:

other: eye flushed after 30 seconds

Irritant / corrosive response data:

Unflushed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision. Flushed eyes scored 69.3/89.3 when flushed at 15 and 30 seconds, respectively. A score of 16 or higher is considered a severe irritant.

Other effects:

No details

Any other information on results incl. tables

Unflushed eyes scored a 110 on the grading scale used, the highest possible. The test material had destroyed the vision. Flushed eyes scored 69.3/89.3 when flushed at 15 and 30 seconds, respectively. A score of 16 or higher is considered a severe irritant.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material is considered to be a severe eye irritant, and there is little beneficial effect even when eyes are almost immediately flushed with water.

Executive summary:

In two studies of the eye irritation potential of AMP in rabbits, AMP was applied to the eyes of 6 rabbits (Strain and sex not recorded). In one study, the eyes were flushed with water 15 to 30 seconds post application, in the second study the eyes were not flushed with water. AMP caused severe damage to the eyes and flushing almost immediately with water appeard to have little beneficial effect. The Damage caused by AMP appears likely to be due to the high pH rather than any other type of chemical damage.