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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:
14.06.1982 - 14.07.1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with restrictions (no details on the test substance; no details of the control group; during induction, the test substance was applied on filter patches after an intracutaneous injection of an adjuvant saline mixture; only one reading after challenge at 24 hours).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
(no details on the test substance; no details on the control group; as first induction step, the test substance was applied on filter patches after an intracutaneous injection of an adjuvant saline mixture; only one reading after challenge at 24 hours)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A valid guinea pig study is available peformed before the LLNA protocol was established

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
EC Number:
279-632-6
EC Name:
Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
Cas Number:
80939-62-4
Molecular formula:
Unspecified
IUPAC Name:
Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ivanovas, Germany
- Age at study initiation: about 10 weeks
- Weight at study initiation: 313-401 g
- Housing: individually in Macrolon cages (type 3)
- Diet (ad libitum): standard guinea pig pellets - NAFAG No. 830
- Water (ad libitum): fresh water, supplemented with fresh carrots
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50 +/- 1
- Photoperiod (hrs dark / hrs light): 10/14

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
10 % of the test substance in vaseline at intradermal/epicutaneous induction; 30 % at challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
10 % of the test substance in vaseline at intradermal/epicutaneous induction; 30 % at challenge
No. of animals per dose:
20 animals (10 males/10 females) in the test group, no details concerning the control group
Details on study design:
RANGE FINDING TESTS: The concentrations of the test compound for induction and challenge periods were determined on separate animals.

A. MAIN STUDY
Test Group:
First induction week: 0.1 ml of a freshly prepared adjuvant saline mixture was injected intracutaneously at 4 sites on the animal's neck. The test compounds were applied on filter patches (2 x 4 cm) to the epidermis over the injection sites for 24 hours under an occlusive dressing.

Second induction week: The test compound was applied in the same way as during the first week for 48 hours occlusively.

Challenge: After a rest period of 14 days the compound was applied on filter paper patches (2 x 2 cm) to an untreated flank skin of the animals for 24 hours epidermal occlusively.

Twenty four hours after removing the dressings the challenge reactions were graded according to the Draize scoring scale.

Control group:
A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30 %
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
two male animals showed very slight erythema (grade 1); results of the control group were not given
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: two male animals showed very slight erythema (grade 1); results of the control group were not given.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU