Registration Dossier

Administrative data

Description of key information

A Guinea Pig Maximization Test (GPMT) was performed on 30 female guinea pigs (20 animals for the test item group and 10 control animals) to determine whether the test item Mesamoll (content: 72.0 %) exhibits skin-sensitizing properties. The study was conducted according to OECD Guideline No. 406/EC Guideline 96/54/EC (22nd Adaptation of Guideline 67/548/EEC)/Health Effects Test Guideline, OPPTS 870.2600 with the following test item concentrations:
Intradermal induction: 5%
Topic induction: 12%
Challange: 3%.
The test item was formulated in polyethylene glycol 400 to yield a solution. The challenge using a 3% test item formulation led to no skin effects in the animals of the treatment group or of the control group. In summary, under the conditions of the maximization test and with respect to the evaluation criteria the test item exhibits no skin-sensitization potential (Vohr H.-W., Bayer AG, 2002).

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline and GLP study.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The GPMT was carried out before the entry into force of the amendments of REACH Annex VII (Regulation (EC) No. 1907/2006)
Species:
guinea pig
Strain:
other: HSD POC:DH
Sex:
female
Route:
other: Guinea pig maximization test
Vehicle:
other: polyethylene glycol 400
Concentration / amount:
Intradermal induction: 5%
Topical índuction: 12%
Challenge: 3%
Route:
other: Guinea pig maximization test
Vehicle:
other: polyethylene glycol 400
Concentration / amount:
Intradermal induction: 5%
Topical índuction: 12%
Challenge: 3%
No. of animals per dose:
30 female guinea pigs.
Details on study design:
1st application: Induction 5 % intracutaneous
2nd application: Induction 12 % occlusive epicutaneous
3rd application: Challenge 3 % occlusive epicutaneous
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
3% (= 15 mg test item/animal)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
The challange using a 3% test item formulation led to no skin effects in the animals of the treatment group
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3% (= 15 mg test item/animal). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: The challange using a 3% test item formulation led to no skin effects in the animals of the treatment group.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
The challange using a 3% test item formulation led to no skin effects in the animals of the control group
Remarks on result:
other: see Remark
Remarks:
Reading: 1st 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: The challange using a 3% test item formulation led to no skin effects in the animals of the control group.
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
3% (=15 mg test item/animal)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
The challange using a 3% test item formulation led to no skin effects in the animals of the treatment group
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3% (=15 mg test item/animal). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: The challange using a 3% test item formulation led to no skin effects in the animals of the treatment group.
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
The challange using a 3% test item formulation led to no skin effects in the animals of the control group
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: The challange using a 3% test item formulation led to no skin effects in the animals of the control group.
Challenge treatment did not cause any effects in test and control animals.
Interpretation of results:
GHS criteria not met
Executive summary:

The Guinea Pig Maximization Test (GPMT) was performed on 30 female guinea pigs (20 animals for the test item group and 10 control animals) to determine whether the test item Mesamoll (content: 72.0 area-%) exhibits skin-sensitizing properties.

The study was conducted according to OECD Guideline No. 406/EC Guideline 96/54/EC (22th Adaptation of Guideline 67/548/EEC)/Health Effects Test Guideline, OPPTS 870.2600 with the following test item concentrations:

Intradermal induction: 5%

Topic induction: 12%

Challange: 3%.

The test item was formulated in polyethylene glycol 400 to yield a solution.

The challange using a 3% test item formulation led to no skin effects in the animals of the treatment group or of the control group.

In summary, under the conditions of the maximization test and with respect to the evaluation criteria the test item exhibits no skin-sensitization potential.

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

Conclusion: The test item exhibits no skin-sensitization potential in a Guinea Pig Maximization Test (GPMT). No information regarding respiratory sensitization is available.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification is not required.