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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:
not mentioned
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study perfromed before the implementation of the REACH regulation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Marlotherm L
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: ambient
- Other: none

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white DHPW (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 301 - 398 g
- Housing: collective housing up to maximum of 5 animals per cage in Makrolon cages type IV
- Diet (e.g. ad libitum): Ssniff G complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 ± 3.5
- Humidity (%): 50 - 85
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: not mentioned

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
5%
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
No. of animals per dose:
test group: 20 animals (10 male, 10 female)
control group: 20 animals (10 male, 10 female)
Details on study design:
RANGE FINDING TESTS:
Intradermal injection: The test articel was diluted with water and FCA to give a final concentration of 5%. Two animals (1 male, 1 female) were employed, skin reactions being recorded 48 h after treatment.
Dermal application: A closed patch exposure was effected by means of an occlusive bandage. Two animals (1 male, 1 female each) were empoyed for each concentration tested (100%; 50%) and skin reactions were recorded 48 h p.a.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 mL); 2nd exposure: epicutaneous for 48 hours
- Concentration in Freunds Complete Adjuvants (FCA): 5 % test substance in a mixture of FCA and water (1:2)
- Test group: dermal: 100 % test substance (2 x 4 cm patch)
- Control group: vehicle (2 x 4 cm patch)
- Frequency of applications: day 0: intradermal treatment, day 7: pretreatment with sodium lauryl sulfate (10% in petrolatum) and day 8: dermal treatment
- Duration: 3 weeks


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance
- Control group: test substance
- Site: left flanks
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after patch removal
Challenge controls:
see above B. Challenge exposure
Positive control substance(s):
yes
Remarks:
2,4 dinitrochlorobenzene, historical control

Results and discussion

Positive control results:
The last periodic use of the positive control substance (2,4 dinitrochlorobenzene) resulted in an acceptable level of response in the test animals, not tested in parallel (no further details mentioned).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Group:
positive control
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

RESULTS OF PILOT STUDY:

Intradermal treatment: no specific findings

Dermal application: no skin irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Benzyltoluene was considered as non-sensitizing in the Guinea Pigs Maximalisation Test.
Executive summary:

The delayed contact hypersensivity of Benzyltoluene was evaluated in Guinea pigs according to OECD N°406 guideline. 20 animals were used as treated group and 20 other animals were used as negative control. The concentrations used for induction were, for intradermal treatment: 5%; and for dermal treatment: 100%. The concentration used in Freund's Complete Adjuvant (FCA) was 5 %. For challenge, the concentration used was 100 %. No skin reaction was observed for none of the animals. Benzyltoluene was considered as non-sensitizing in the Guinea Pigs Maximalisation Test.