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Diss Factsheets

Administrative data

Description of key information

To evaluate the sensitization potential of the test item, a GPMT according to GLP and OECD 406 was performed.

The substance did not induce a sensitizing effect in guinea pigs after 24/48 h challenge.

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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
According to Regulation 1907/2006, Annex VII, 8.3.2 a skin sensitisation study that was carried out or initiated before 10 May 2017, and that meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4) shall be considered appropriate to address this standard information requirement.
The guinea pig maximisation test was performed according to OECD 406 and GLP in the year 2000 and is acceptable to fullfill the information requirements.
Species:
guinea pig
Strain:
Himalayan
Remarks:
Ibm:GOHI; SPF synonym: Himalayan spotted
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Fuellinsdorf/ Switzerland
- Age at study initiation: 349 - 412 g
- Weight at study initiation: 4 - 6 weeks
- Housing: Individually
- Diet (e.g. ad libitum): Pelleted standard Nafag Ecosan 845 25W4, batch nos. 79/99 and 85/99, guinea pig breeding / maintenance diet, containing
Vitamin C ("Nafag", Naehr- und Futtermittel AG, Gossau), ad libitum
- Water (e.g. ad libitum): Community tap water from Fuellinsdorf, ad libitum
- Acclimation period: One week for the control and test group. No acclimatization for the animals of the pretest.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
Route:
intradermal and epicutaneous
Vehicle:
other: PEG 400
Concentration / amount:
Intradermal injections: 3 %
Epidermal occl. patch induction: 50%
Challenge: 50%
Route:
epicutaneous, occlusive
Vehicle:
other: PEG 400
Concentration / amount:
Intradermal injections: 3 %
Epidermal occl. patch induction: 50%
Challenge: 50%
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
RANGE FINDING TEST: To determine the different concentrations an intradermal and epidermal pretest was performed.
Intradermal injections: 1, 3, 5 %
Epidermal occl. patch induction: 10, 15, 25 and 50%
Challenge: 50%

MAIN STUDY
A. INDUCTION EXPOSURE
I.) INTRADERMAL INJECTIONS
- Test groups: 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. 2) The test article, at 3 % in PEG 400. 3) The test article at 3 % in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Control group: 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. 2) PEG 400. 3) 1:1 (w/w) mixture of PEG 400 in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Site: area of dorsal skin from the scapular region
- Frequency of applications: Three pairs of intradermal injections given once

II.) EPIDERMAL APPLICATIONS
On test day 7 and approximately 24 hours prior to the epidermal application the scapular area (approximately 6 x 8 cm) of the animals of the control and test group was pretreated with 0.5 ml of 10 % Sodium-Lauryl-Sulfate (SLS) in paraffinum perliquidum as no primary irritation had been observed in the pretest. The SLS was massaged into the skin with a glass rod without bandaging. This 10 % concentration of SLS enhances sensitization by provoking a mild inflammatory reaction.
On test day 8, a 2 x 4 cm patch of filter paper was saturated with the test article (50 % in PEG 400) and placed over the injection sites of the test animals. The amount of test article preparation applied was approximately 0.3 g. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The occlusive dressings were left in place for 48 hours.
The guinea pigs of the control group were treated as described above with PEG 400 only, applied at a volume of approximately 0.3 ml.
The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.

B. CHALLENGE EXPOSURE
- Day(s) of challenge: The test and control guinea pigs were challenged two weeks after the epidermal induction application and were treated in the same way.
- Exposure period: 24 hours
- Site: left and right flank of each guinea pig
- Concentrations: The amount of test article preparation applied was approximately 0.2 g and a volume of approximately 0.2 ml was used for the vehicle
- Evaluation (hr after challenge): The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.
Challenge controls:
yes, PEG 400
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole (CAS No. 149-30-4). Validation of assay indicated by frequent tests in the lab
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10 %
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 %
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
The substance did not induce a sensitizing effect in guinea pigs after 24/48 h challenge.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In order to assess the cutaneous allergenic potential of the test substance, the Maximization-Test was performed in 15 (10 test and 5 control) male albino guinea pigs, in accordance with OECD Guideline 406 and GLP conform.

The intradermal induction of sensitization in the test group was performed in the nuchal region with a 3 % dilution of the test article in PEG 400 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test article at 50 % in PEG 400 one week after the intradermal induction and following pretreatment of the test areas with 10 % Sodium-Lauryl-Sulfate (SLS) approximately 24 hours prior to application of the test article.

The animals of the control group were intradermally induced with PEG 400 and FCA/physiological saline and epidermally induced with PEG 400 under occlusion following pretreatment with 10 % SLS.

Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test article at 50 % in PEG 400 and PEG 400 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No toxic symptoms were evident in the guinea pigs of the control or test group. None of the control and test animals showed skin reactions after the challenge treatment with the test substance at 50 % (w/w) in PEG 400. The test material is therefore not regarded as skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2018/1480. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.