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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:
1982-06-14 to 1982-07-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
(no pos. control in study (pos. controls regularly tested in facility), no data on test material purity, vehicle not specified, first induction is epidermal, only one reading 24 hours after challenge, application sites chemically depilated before reading)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A valid GPMT is available, therefore an LLNA is not required.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ivanovas, Germany
- Age at study initiation: 10 weeks
- Weight at study initiation: 310 - 425 g
- Housing: Individually in Macrolon cages (type 3)
- Diet: Standard guinea pig pellets, NAFAG No. 830, Gossau SG, ad libitum
- Water: ad libitum, supplemented with fresh carrots
- Acclimation period: 12 days

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

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: not specified
Concentration / amount:
10%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: not specified
Concentration / amount:
30%
No. of animals per dose:
10 males and 10 females
Details on study design:
RANGE FINDING TESTS:
The concentrations of the test compound for induction and challenge periods were determined on seperate animals.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 exposures: Intracutanous injection of adjuvant at 4 sites of the animal's neck prior to induction. First induction: Occlusive epidermal application of the test substance and second induction again as occlusive epidermal application of the test substance.
- Exposure period: Day 1: Epidermal exposure to test substance for 24 hours at first induction and one week later second epidermal induction application for 48 hours.
- Test groups: 0.1 ml of a freshly prepared adjuvant saline mixture was injected intracutanously at 4 sites on the animal's neck. The test compound was applied on filter patches (2 x 4 cm) to the epidermis over the injection sites under an occlusive dressing. One day before second induction the animals were pretreated with 10 % sodium laurylsulphate (open application).
- Control group: A control group was treated with adjuvant and the vehicle.
- Site: Neck
- Frequency of applications: 2 occlusive epidermal applications (see above)
- Duration: Day 1 epidermal application for 24 hours, after one week epidermal application for 48 hours.
- Concentrations: 10 % test substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after induction
- Exposure period: 24 hours
- Test groups: 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.
- Control group: The control group was treated with the vehicle as well as with the test substance to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
- Site: Flank
- Concentrations: 30 % test substance
- Evaluation (hr after challenge): 24 hours after patch removal
- The application sites were chemically depilated before examination (Veet, 5 minutes)
Challenge controls:
20 animals (vehicle control)
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: vehicle control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group:
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30 %
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 3.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met