Didecyldimethylammonium chloride

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 Dec, 1995 - 5 Jan, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

Buehler test

Justification for non-LLNA method:

The study was conducted before the requirement for LLNA testing came into force.

Test material

Test material information

Constituent 1

Reference substance name:

Didecyldimethylammonium chloride

EC Number:

230-525-2

EC Name:

Didecyldimethylammonium chloride

Cas Number:

7173-51-5

Molecular formula:

C22H48N Cl

IUPAC Name:

didecyldimethylammonium chloride

Details on test material:

Test substance: as prescribed by 1.2 as typical marketed susbstance (act; 50%, ipa:20%, water: 30%)

Composition: ca. 50% Didecyldimethylammonium chloride (CASno.: 7173-51-5) and 20% isopropanol (CASno.: 67-63-0) in water.
Batch FP95159

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

Species: Guinea pigs
Strain: Dunkin Hartley strain, albino guinea pig (SPF-quality)
Source: Charles River, Germany
Sex: Females
Age/weight at study initiation: Approx. 5 weeks 381 - 463 grams
Number of animals per group: 20 animals tested
Control animals: Yes: 10 animals

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

Induction dose: 2 %
Challenge dose: 1 %

Challenge

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

Induction dose: 2 %
Challenge dose: 1 %

No. of animals per dose:

20

Details on study design:

1st application: Induction 2 % occlusive epicutaneous
2nd application: Challenge 1 % occlusive epicutaneous

Positive control substance(s):

yes

Remarks:

1-Chlor-2,4-dinitrobenzol

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1% in water

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

1st reading

Group:

negative control

Dose level:

water

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Results 3

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

positive control

Dose level:

5% 1-chlor-2,4-dinitrobenzol

No. with + reactions:

9

Total no. in group:

9

Remarks on result:

positive indication of skin sensitisation

Any other information on results incl. tables

Slight to severe oedema, well defined to severe erythema and necrotic areas were observed in the treated skin areas in the experimental animals after the third 6 hours epidermal induction exposure (day 15). In the challenge phase, skin reactions of grade 1 were observed in two experimental and two control animals 24 hours after exposure only in response to a 1% test substance concentration. No skin reactions were observed in response to the vehicle in any of the experimental and control animals. Taking into account the intensity of the responses and comparing these with the skin reactions seen in the control animals, it was considered that no experimental animals had induced hypersensitivity to the test substance. These results lead to a sensitisation rate of 0 per cent.

Applicant's summary and conclusion

Conclusions:

The test substance was found to be non-sensitizing to the skin in the guinea pigs.

Executive summary:

A study was conducted to determine the skin sensitisation potential of the test substance in guinea pigs following the Buehler protocol. Twenty test guinea pigs were treated on three occasions during 6 h with 2% test substance. Ten control animals were treated with vehicle only. Fourteen days later, all animals were challenged with 1% test substance and vehicle (distilled water). Slight to severe oedema, well defined to severe erythema and necrotic areas were observed in the treated skin in of experimental animals after the third 6 h epidermal induction exposure (Day 15). In the challenge phase, skin reactions of grade 1 were observed in two experimental and two control animals 24 h after exposure only in response to a 1% test substance concentration. No skin reactions were observed in response to the vehicle in any of the experimental and control animals. Taking into account the intensity of the responses and comparing these with the skin reactions seen in the control animals, it was considered that no experimental animals had induced hypersensitivity to the test substance. These results lead to a sensitisation frequency of 0%. Taking into account the intensity of the responses and comparing the test and control animals, it can be concluded that the test substance did not cause hypersensitisation in the guinea pig when tested according to Buehler protocol (NOTOX, 1996).