Amines, C12-18-alkyl, reaction products with acrylic acid, sodium salts

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1963

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted prior to the implementation of current testing guideline and GLP, however according to a still accepted testing method (Draize, 1944). Basic data were given and thus, the study is considered to be acceptable. The study was performed on an analogue substance (for justification of read-across, please refer to the corresponding assessment report in Section 13).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

Materials and methods

Principles of method if other than guideline:

The testing method was based on the Draize test as described in Draize et al. (1944), J Pharm and Exp Ther 82. Each of ten guinea pigs received a series of 10 injections of 0.1% test item solution, every other day, in a depilated skin region below the midline of the back. The first injected volume was 0.05 mL, the following injected volumes were 0.1 mL each. After 2 weeks following the last induction injection, challenge was conducted by injection of 0.05 mL of the test solution in the skin of the flank. The injection site was examined for skin reaction after a period of 24 hours following challenge.

GLP compliance:

no

Type of study:

Draize test

Justification for non-LLNA method:

Test in guinea pigs available before it was decided to register the substance.

Test material

Test material information

Constituent 1

Reference substance name:

Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate

EC Number:

239-032-7

EC Name:

Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate

Cas Number:

14960-06-6

IUPAC Name:

Sodium Lauriminodipropionate

Test material form:

other: liquid

Details on test material:

- Common name : Sodium lauriminodipropionate
- For more details, see below the Confidential details for test material

Specific details on test material used for the study:

Form: Liquid
The study was performed on a commercial product (aqueous solution) as the test item is manufactured and used in a liquid form.

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: not specified
- Weight at study initiation: 350 - 450 g
- No further details provided

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

0.1%

Day(s)/duration:

20 days, 10 injections

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

0.1%

Day(s)/duration:

14 days after last induction

Adequacy of challenge:

not specified

No. of animals per dose:

10

Details on study design:

A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 20 days
- Site: depilated skin region below the midline of the back
- Frequency of applications: injection was done every other day
- Concentrations: 0.1% test item solution
- Injected volume: 0.1 mL, except for the first injection (0.05 mL)
- Reading: skin readings were made at the injection sites, 24 hours after each injection had been done; the skin was examined for diameter, heigh and colour.

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Challenge: done after 2 weeks following the last induction injection
- Site: skin of the flank.
- Concentrations: 0.1% test item solution
- Injected volume: 0.05 mL
- Evaluation (hr after challenge): 24 hours

READING
The application site was examined for diameter, heigh and colour. The readings were compared with those made at the sites of the first injection series (induction). If the reactions after challenge were appreciably more pronounced than those observed during induction, the test item was defined as a sensitizer. The degree of sensitization was considered to be, in part, proportional to the observed increase in skin reaction.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Group:

positive control

Dose level:

0

No. with + reactions:

0

Total no. in group:

0

Remarks on result:

not measured/tested

Results 2

Reading:

1st reading

Group:

negative control

Dose level:

0

No. with + reactions:

0

Total no. in group:

0

Remarks on result:

not measured/tested

Results 3

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Skin reaction at induction was characterized by a mean diameter of 3.6 mm, a mean height of < 1 mm, and a pink coloration (indicates slight erythema). Reaction after challenge had a mean diameter of 3.5 mm, a mean height of < 1mm, and a pink coloration.

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

Sodium lauiminodipropionate, as a 10% aqueous solution, was tested at a concentration of 0.1% for sensitization according to the method of Draize (1944) using ten guinea pigs. Induction consisted of a series of 10 injections of 0.1 mL of test solution, except for the first injection done with 0.05 mL; the injections were done every other day over a period of 20 days. After 2 weeks following the last induction injection, challenge was done by single injection of 0.05 mL of the 0.1% test solution; skin reading was done after 24 hours.

Since no obvious differences were noticed when comparing the skin reaction at induction and that after challenge, sodium lauriminodipropionate was considered not to be a skin sensitizer unter the test conditions used.