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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study, but positive control data not available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
(positive control data not available)
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5-dimethoxyaniline
EC Number:
203-040-9
EC Name:
2,5-dimethoxyaniline
Cas Number:
102-56-7
Molecular formula:
C8H11NO2
IUPAC Name:
2,5-dimethoxyaniline
Details on test material:
- Name of test material (as cited in study report): Aminohydrochinondimethylether

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White guinea pig
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, breeding colony
- Weight at study initiation: 275 - 357 g
- Housing: in fully air·conditioned rooms in Makrolon cages on soft wood granulate, in groups of 5 animals
- Diet (e.g. ad libitum): Standard feed for guinea pigs and rabbits (Altromin 3112), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3
- Humidity (%): 50 +-20
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: deionisied water
Concentration / amount:
Determination of the primary non·irritant concentration: 0.5 g Aminohydrochinondimethylether moistened with 0.35 mL deionised water
Induction treatment: 0.5 g Aminohydrochinondimethylether moistened with 0.35 mL deionised water
Challenge treatment: 0.5 g Aminohydrochinondimethylether moistened with 0.35 mL deionised water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: deionisied water
Concentration / amount:
Determination of the primary non·irritant concentration: 0.5 g Aminohydrochinondimethylether moistened with 0.35 mL deionised water
Induction treatment: 0.5 g Aminohydrochinondimethylether moistened with 0.35 mL deionised water
Challenge treatment: 0.5 g Aminohydrochinondimethylether moistened with 0.35 mL deionised water
No. of animals per dose:
Determination of primary non-irritant concentration: 2 animals
Control group: 10 animals
Treated group: 20 animals
Details on study design:
Main test

Day 1-15
During this test phase, the following procedures were carried out once a week. For the dermal treatments, 0.5 g Aminohydrochinondimethylether moistened with 0.35 mL deionised water was applied in evenly over a 2 x 2 cm cellulose patch, which was fixed to the front part of the left flank of the 20 animals of the treatment group and then covered with an occlusive polyethylene film and a bandage. 10 control animals were treated analogously with 0.5 mL deionised water. After an exposure period of 6 hours the occlusive bandage was removed and the flank skin washed. Clinical signs and irritant effects emerging during the sensitization phase were recorded.

Day 16-28
Animals under observation

Day 29
Challenge treatment.This took place under identical conditions for control and treated animals alike. The hair of the previously untreated right flank was removed mechanically. Challenge treatment was performed with 0.5 g Aminohydrochinondimethylether moistened with 0.35 mL deionised water. The test substance preparation was applied to a cellulose patch, which was placed on the hind part of the right flank and covered with an occlusive bandage. Exposure was for 6 hours. After removal of the occlusive bandage, any remnants of the substance were carefully washed off with warm water.

Day 30
Macroscopic examination of the skin.

Day 31
Macroscopic examination of the skin. Terminal body weight determination.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not reported in this study report. It is likely that positive control results are reported separately.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: reading after 1st treatment
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: other: reading after 1st treatment. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
other: reading after 1st treatment
Group:
test chemical
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: other: reading after 1st treatment. Group: test group. Dose level: 0.5 g. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
other: reading after 2nd treatment
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: other: reading after 2nd treatment. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
other: reading after 2nd treatment
Group:
test chemical
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: other: reading after 2nd treatment. Group: test group. Dose level: 0.5 g. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
other: reading after 3rd treatment
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: other: reading after 3rd treatment. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
other: reading after 3rd treatment
Group:
test chemical
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: other: reading after 3rd treatment. Group: test group. Dose level: 0.5 g. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 g. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 g. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the results of this study Aminohydrochinondimethylether showed no evidence for sensitizing properties.
Executive summary:

Testing for sensitizing properties of Aminohydrochinondimethylether was performed in female guinea pigs according to OECD 406, method of BUEHLER. Dermal induction was performed using 100 % Aminohydrochinondimethylether (moistened with deionised water) . The control group was exposed to deionised water only. Challenge treatment was carried out with 100 % Aminohydrochinondimethylether (moistened with deionised water). Based on the results of this study Aminohydrochinondimethylether showed no evidence for sensitizing properties.