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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-05-11 to not provided
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted equivalent to a guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
please refer to "Principles of method"
Principles of method if other than guideline:
The guinea pig maximization test was conducted according to Magnusson, B. and Kligman, A.M. (eds.): Identification of Contact Allergens in Allergic Contact Dermatitis in the Guinea Pig, C.C. Thomas, Illinois, USA; pp. 102-123. This test method was later included into the OECD Guideline 406.
Deviations from the protocol in the report were:
- The protocol states the room will be air-conditioned with the air temperature maintained at 18 °C +/- 3 °C and relative humidity of 60 % (+ 10 %). Temperature range recorded during the study was 16- 22°C. Humidity range recorded during the study was 52- 81 % (air-conditioning unit not functioning correctly).
- Protocol states main tap water containing 0.1 % ascorbic acid will be freely available. During the study tap water containing 0.01 % ascorbic acid was freely available (Error in original protocol, 0.01% is the level of ascorbic acid for this type of study).
- Protocol specifies the use of Whatmans Number 1 filter paper in topical applications. Whatman Number 3 paper was used throughout the study (Whatman Number 1 paper was not available).
- Protocol specifies the challenge application is carried out at a single concentration of the test material. The challenge was conducted using two concentrations of test material (Standard Toxicol Laboratories Procedure, carried out in error for this study).
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Information from in vivo test other than LLNA was already available before LLNA guideline was in place.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4-dichlorobenzyl alcohol
EC Number:
217-210-5
EC Name:
2,4-dichlorobenzyl alcohol
Cas Number:
1777-82-8
Molecular formula:
C7H6Cl2O
IUPAC Name:
(2,4-dichlorophenyl)methanol

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: accredited breeder
- Age at study initiation:
- Weight at study initiation: 300-400 g
- Housing: groups of max.. 5 animals
- Diet: ad libitum, TR2 with added vitamin C manufactured and supplied by Pilsbury's Birmingham,
- Water: ad libitum, containing 0.01 % vitamin C

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 52-81
- Photoperiod (hrs dark / hrs light): 10/14

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: ethanol
Concentration / amount:
Induction Phase: Injection, 50 % concentration of the test material in ethanol, with and without FCA
Induction Phase: Topical Application, 50 % concentration of the test material in ethanol
Challenge Phase: 50 % and 25 % concentrations of the test material in ethanol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
Induction Phase: Injection, 50 % concentration of the test material in ethanol, with and without FCA
Induction Phase: Topical Application, 50 % concentration of the test material in ethanol
Challenge Phase: 50 % and 25 % concentrations of the test material in ethanol
No. of animals per dose:
20 test animals and 8 control animals, and 4 animals for the dose finding test
Details on study design:
RANGE FINDING TESTS: Performed in 4 animals pretreated with FCA. Concentrations of 50, 25, 12.5, 6.25 % were used in topical application (occlusive) for 24 h. After 24 h and 48 h sites were scored and maximum non-irritant concentration was selected.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (1 injection, 1 topical application)
- Exposure period: : Injection, 7 days later 48 h exposure to topical application
- Control group: vehicle control group (ethanol) with the same form of applications
- Site: shoulder region, 4*2 cm area
- Frequency of applications: 2 times (1 injection, 1 topical application)
- Duration: 48 h for topical application
- Concentrations: 50 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 14 days after topical induction
- Exposure period: 24 h
- Site: flanks of the animals
- Concentrations: 50 % on one flank, 25 % on the other flank
- Evaluation (hr after challenge): 24 and 48 h after removal
Challenge controls:
One vehicle control group was done.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
1 animal died during the study
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: 1 animal died during the study.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
1 animal died during the study
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: 1 animal died during the study.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
1 animal died during the study
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: 1 animal died during the study.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
1 animal died during the study
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: 1 animal died during the study.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 8.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 8.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 8.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 8.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information