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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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).

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.

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.

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

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

0.1%

Day(s)/duration:

20 days, 10 injections

Adequacy of induction:

not specified

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.

Reading:

1st reading

Group:

positive control

Dose level:

0

No. with + reactions:

0

Total no. in group:

0

Remarks on result:

not measured/tested

Reading:

1st reading

Group:

negative control

Dose level:

0

No. with + reactions:

0

Total no. in group:

0

Remarks on result:

not measured/tested

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Sodium lauriminodipropionate, as a 10% solution in water, was tested at a concentration of 0.1% for sensitization according to the method of Draize (1944) using ten guinea pigs. Since no obvious differences were observed when comparing the skin reaction at induction and that after challenge, the test substance was considered not to be a skin sensitizer under the test conditions used.

The reliability of these experimental results was considered sufficient to include this study as a key study for the present endpoint.

No valid information on respiratory sensitisation is available.

Migrated from Short description of key information:
Skin sensitisation:
- guinea-pig, Draize protocol (10% active ingredient), 0.1% induction (by injection): not sensitising, 0/10 positive (BASF, IBT 4451,1963)

Justification for selection of skin sensitisation endpoint:
Most reliable relevant study

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Migrated from Short description of key information:
Respiratory sensitisation:
-No data available

Justification for classification or non-classification

Skin sensitisation:

According to GHS and DSD criteria, substances shall be classified as skin sensitiser if there are positive results from appropriate animal tests. A skin sensitisation test with guinea pigs according to Draize protocol (BASF, IBT 4451,1963) showed no positive findings (0/10 tested animals) on a close analogue. Hence disodium cocoiminodipropionate needs not to be classified as sensitising to skin according to GHS (Regulation (EU) 1272/2008) or DSD (67/548/EEC).

 

Labelling for sensitisation:

GHS: no label

DSD: no label

 

Respiratory sensitisation:

No data available