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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 14, 1985 to February 7, 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The experiment has been carried out before LLNA implementation (2002)

Test material

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Age at study initiation: 6-8 weeks
Weight at study initiation: 200-350 g
Housing: Makrolon cages, 5 per cage
Diet (e.g. ad libitum): 8GP17 guinea pig food, ad libitum
Water (e.g. ad libitum): ad libitum
Temperature (°C): 22 +/- 2
Humidity (%): 60 +/- 20
Air changes (per hr): 15
Photoperiod (hrs dark / hrs light): 12 h/12 h

Study design: in vivo (non-LLNA)

Induction
Route:
other: intracutaneously and epicutaneously
Vehicle:
water
Concentration / amount:
25% in water and Freund's Adjuvant
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
12.5% in deionized water
No. of animals per dose:
10 males and 10 females
Details on study design:
Induction:
Induction was first done by intradermal injection. Test animals were injected with 0.1 mL Freund's Complete Adjuvant (FCA), 0.1 mL of 25% test substance in water, and 0.1 mL test substance in FCA in water (final concentration 25%). Control group was treated in a similar manner with only FCA and water. On Day 7, a second, epicutaneous challenge was done. 0.5 mL of test susbtance (25%) was placed on gauze, and then placed on the animals. The animals were then bandaged, and the test substance remained in contact for 48 h. Control animals were exposed to vehicle only.

Challenge:
0.2 mL of 12.5 % test substance was placed on gauze, which was then placed on the test and control animals. Gauze containing only vehicle was placed on the left flank. The exposure lasted 24 h. Observations for irritation were made at 24 and 48 h after the end of exposure. Skin was scored for irritation using the Draize scale.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
-

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12.5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no positive responses were observed
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
12.5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no positive responses were observed
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the substance was not sensitizing to guinea pig skin.
Executive summary:

A study was conducted to determine the skin sensitisation potential of the substance according to OECD Guideline 406, in compliance with GLP. Ten male and ten female Hartley guinea pigs were included in the experiement. The induction was first done by intradermal injection. Test animals were injected with 0.1 mL Freund Complete Adjuvant (FCA), 0.1 mL of 25% test substance in water, and 0.1 mL test substance in FCA in water (final concentration 25%). Control group was treated in a similar manner with only FCA and water. On Day 7, a second, epicutaneous challenge was done. 0.5 mL of test susbtance (25%) was placed on gauze, and then placed on the animals. The animals were then bandaged, and the test substance remained in contact for 48 h. Control animals were exposed to vehicle only. The challenge consisted of 0.2 mL of 12.5 % test substance placed on gauze, which was then placed on the test and control animals. Gauze containing only vehicle was placed on the left flank. The exposure lasted 24 h. Observations for irritation were made at 24 and 48 h after the end of exposure. Skin was scored for irritation using the Draize scale. No positive reactions were noted. Under the study conditions, the substance was not sensitizing to guinea pig skin (RBM, 1985).