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Diss Factsheets

Administrative data

Description of key information

The test substance was devoid of skin sensitizing properties when studied in Guinea Pig maximization tests.

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:
21.11.1983 - 22.12.1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: - A pilot study was routinely performed in the test laboratory, but results are not reported.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Valid test data with guinea pigs are available, no further studies are required.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in-house bred
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 332-478 g
- Housing: individually in Macrolon cages (type 3)
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 846, Gossau SG - supplemented with fresh carrots.
- Water: ad libitum)
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 50±10
- Photoperiod (hrs dark / hrs light): 10/14
Route:
intradermal and epicutaneous
Vehicle:
other: sesame oil for intradermal and vaseline for epidermal
Concentration / amount:
- Concentrations used for induction: 1% in sesame oil for intradermal and 10% in vaseline for epidermal induction
- Concentrations used for challenge: 1% in vaseline
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil for intradermal and vaseline for epidermal
Concentration / amount:
- Concentrations used for induction: 1% in sesame oil for intradermal and 10% in vaseline for epidermal induction
- Concentrations used for challenge: 1% in vaseline
No. of animals per dose:
10/sex
Details on study design:
RANGE FINDING TESTS
The concentrations of the test compound for induction and challenge period were determined on separate animals.

MAIN STUDY
A. INDUCTION EXPOSURE
Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea pigs with a mixture of adjuvant and saline, with the test compound in sesame oil and with the test compound in the adjuvant saline mixture. One week later test material was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours).
- Control group: treated with adjuvant and the vehicle during the induction period
- Concentrations: 1% for intradermal and 10% for epidermal induction

B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the animals were tested on the flank with 1% test material in vaseline and the vehicle alone (24 h occlusive application). Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. The application sites were chemically depilated 3 hours before examination (Veet, 5 minutes). A second evaluation is made 48 hours after removing the
dressings. During the challenge period
the group was
- Control group: 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.
- Concentrations: 1%
Positive control substance(s):
yes
Remarks:
p-phenylenediamine
Positive control results:
The sensitivity of the strain is controlled every six month with p-phenylenediamine, but the results are not reported.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0.

ADDITIONAL RESULTS OF TEST

- Body weight gain: no treatment-related effects

- Clinical signs: none reported

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No animal showed a sensitization reaction (0/20) and the test article is considered as not sensitizing.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A guinea pig maximization study was carried out according to the OECD protocol No. 406 Ciba-Geigy, 1984). The test was performed on ten male and then female animals. Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea pigs with a mixture of adjuvant and saline, with the test compound in sesame oil and with the test compound in the adjuvant saline mixture. One week later the test article was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours). Two weeks after the epidermal induction application the animals were tested on the flank with 1% test material in vaseline and the vehicle alone (24 h occlusive application). Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings. 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. No animal was sensitized under the experimental conditions employed. Accordingly, the test item is considered to have no dermal sensitization potential. Similar results were reported in two supporting studies.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

There are conclusive but not sufficient data for classification of the test item with regard to sensitization. The test item is not classified for this endpoint in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 1272/2008 as well as GHS regulations.