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Diss Factsheets

Administrative data

Description of key information

not sensitising

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:
1995-07-24 to 1995-08-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was conducted in 1995 and was considered as appropriate to cover this endpoint. The test substance is hydrolytically instable.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: HOE CG 0501 0DZD00 0001
- Expiration date of the lot/batch: June 1996

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: darkness at room temperature in a fume cupboard
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: guaranteed for 4 h

Species:
guinea pig
Strain:
other: Pirbright-White guinea pig
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany, SPF breeding colony
- Weight at study initiation: 377g -5.6%/+8.2%
- Housing: Makrolon cages in fully air conditioned rooms
- Diet: ssniff Ms-H (V2233) ad libitum
- Water: ad libitum
- Acclimation period: not necessary, breeding at identical conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light):12/12
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 %
Day(s)/duration:
14
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
50 %
Day(s)/duration:
on day 29
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
control group: 10, test group: 20
Details on study design:
RANGE FINDING TESTS:
The primary non-irritant concentration was determined using the concentrations: 100%, 50% and 10% in petrolatum.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 14 days
- Test groups: 20 animals were treated with the undiluted substance
- Control group: 10 control animals treated with vehicle
- Site: left flank
- Frequency of applications: once a week
- Duration: 6h
- Concentrations: 100 %, control group: vehicle

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 29
- Exposure period: 6 h
- Test groups: 50 % test substance in vehicle
- Control group: vehicle only
- Site: right flank
- Concentrations: 50 %
- Evaluation (hr after challenge): 24 h

Challenge controls:
none
Positive control substance(s):
no
Positive control results:
no positive control
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 % substance in petrolatum
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 % test substance in petrolatum
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation

Signs of irritation during induction:

Partly very slight up to moderate erythma and very slight oedema were observed in the treatment group. After the 3. application in 2 test animals the treated skin was dry and rough. The control animals showed no irritations.


Interpretation of results:
GHS criteria not met
Conclusions:
The test substance did not cause skin sensitisation in this Bühler assay.
Executive summary:

In order to test for the sensitizing property of the test substance by the Buehler method, 6 Pirbright White guinea pigs were used to determine the primary non-irritant concentration to be used for the challenge applications, 10 animals served as control during the main test and were only treated with the vehicle (petrolatum), and further 20 animals were used as test group.

All applications were carried out using occlusive dressing and for a duration of 6 hours.

In the preliminary test the following concentrations were used: 100 %, 50 % and 10 %, 50 % was found to be the highest concentration not causing dermal irritation.

During induction, the test substance was administered undiluted to the left flank of all test animals. 3 applications were carried out during the induction phase (day 1-15). After the third application the treated skin of two animals was dry and rough. No treatments were carried out on days 16 to 28. On days 29 the challenge treatment was conducted using 50 % test-substance .

Examinations of the skin followed on the next day (30) and on days 31. No changes/signs of irritation occurred after the challenge treatment.

The test material showed no evidence for sensitizing property.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In order to test for the sensitizing property of the test substance by the Buehler method, 6 Pirbright White guinea pigs were used to determine the primary non-irritant concentration to be used for the challenge applications, 10 animals served as control during the main test and were only treated with the vehicle (petrolatum), and further 20 animals were used as test group.

All applications were carried out using occlusive dressing and for a duration of 6 hours.

In the preliminary test the following concentrations were used: 100 %, 50 % and 10 %, 50 % was found to be the highest concentration not causing dermal irritation.

During induction, the test substance was administered undiluted to the left flank of all test animals. 3 applications were carried out during the induction phase (day 1-15). After the third application the treated skin of two animals was dry and rough. No treatments were carried out on days 16 to 28. On days 29 the challenge treatment was conducted using 50 % test-substance .

Examinations of the skin followed on the next day (30) and on days 31. No changes/signs of irritation occurred after the challenge treatment.

The test material showed no evidence for sensitizing property.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.