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Administrative data

Description of key information

Skin sensitisation (in vivo, Buehler, similar to OECD 406): 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The test was performed in 1997 before the alternative OECD guidelines (LLNA and in vitro test methods) were offically available.
Species:
guinea pig
Strain:
other: HsdPOC: DH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days



Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.5%
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.1%
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
Determination of the non-irritating concentration in the induction phase

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: right flank
- Frequency of applications: days 1, 8, 15
- Duration: 15 days
- Concentrations: 0.5%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: test day 29
- Exposure period: 6 h
- Test groups: 1
- Control group: 10 animals (no second challenge was performed and 10 control animals were left untreated)
- Site: right flank (test substance) left flank vehicle
- Concentrations: 0.1%
- Evaluation (hr after challenge): 24 and 48 hours


Challenge controls:
Animals of control group
Positive control substance(s):
yes
Remarks:
Proof of sensitivity was done in July/August 1996 with 1,4-phenylenediamine x 2 HCl in Guinea Pigs (ASTA Study No. 913105)
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: vehicle 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.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
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%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: vehicle 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.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1%
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%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
1st reading
Group:
positive control
Dose level:
not given in the report
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Erythema and edema
Interpretation of results:
GHS criteria not met
Conclusions:
Substance has no skin sensitising properties under conditions tested.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In the key study skin sensitisation was investigated in a Buehler protocol conducted similar to OECD guideline 406 (96-0068-DGT) in compliance with GLP. Twenty male/female HsdPOC:DH guinea pigs were induced epicutaneously under occlusive conditions with 0.5% test substance formulated in water on day 1, 8 and 15 for 6 hours and challenged epicutaneously (occlusive) with 0.1% test substance formulated in water for 6 hours on Day 29. The concentration was selected as the highest non-irritating concentration, based on the results of a preliminary range-finding test. The skin reactions were assessed 24 and 48 h after patch removal. Proof of sensitivity was done in the same year with 1,4-phenylenediamine x 2 HCl in Guinea Pigs.

24 and 48 h after challenge, all test item treated animals (20/20) showed no skin sensitising reactions. 10/10 animals of the positive control group, thereby confirming the sensitivity of the test.

Under the conditions of the test and based on the experimental findings, the test item is considered to be not sensitising to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation do not meet the criteria for classification as Skin Sensitiser according to Regulation (EC) No. 1272/2008 (CLP) and according to the criteria of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations.

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