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Diss Factsheets

Administrative data

Description of key information

In a study similar to OECD TG 406 the test item was detected as skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 May 1986 - 01 June 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed before the OECD guidline 429 (LLNA) entered into force.
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shizuoka Laboratory Animal Center (Shizuoka, Japan)
- Age at study initiation: 6 weeks old
- Weight at study initiation: 337 - 440 g, Mean : 387.1 g, SD : 20.9 g
- Housing: Steel mesh cage (26 x 38 x 20 cm), 2 animals/cage
- Diet: RC-4 (Oriental Yeast Co., Ltd. (Tokyo, Japan))
- Water: tap water, ad libitum
- Acclimation period: 1 week (quarantine)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (mean)
- Humidity (%): 68 (mean)
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12 / 12
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
3.5 % (w/v)
Day(s)/duration:
day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: white vaseline
Concentration / amount:
42 % (w/w)
Day(s)/duration:
7 days after intra dermal injection / 48 hours
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: white vaseline
Concentration / amount:
42 % (w/w)
Day(s)/duration:
2 weeks after epicutaneous application / 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Intradermal injections: three pairs of injections [1) Freund's Complete Adjuvant emulsion, 2) test item without adjuvant, 3) Mixture of Freund's Complete Adjuvant and test item); Epicutaneous application: one application]
- Exposure period: Epicutaneous application: 48 hours
- Test group: 20 animals, treated with test substance
- Control group: 20 animals, treated with 2,4-dinitrochlorobenzene
- Site: dorsal side
- Frequency of applications: Intradermal injections: one application, Epicutaneous application: one application
- Duration: Epicutaneous application: 48 hours
- Concentrations: Intradermal injections: 3.5 % (w/v), Epicutaneous application: 42 % (w/w)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 2 weeks after epicutaneous application
- Exposure period: 24 hours
- Test group: 20 animals, treated with test substance
- Control group: 20 animals, treated with 2,4-dinitrochlorobenzene
- Site: right flank
- Concentrations: 42 % (w/w)
- Evaluation (hr after challenge): 24, 48 and 72
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene
Positive control results:
Positive skin reactions were observed in all guinea pigs treated with the positive control.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Intradermal injections: 3.5 % (w/v), Epicutaneous application: 42 % (w/w)
No. with + reactions:
20
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Intradermal injections: 3.5 % (w/v), Epicutaneous application: 42 % (w/w)
No. with + reactions:
19
Total no. in group:
20
Key result
Reading:
other: 3nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
Intradermal injections: 3.5 % (w/v), Epicutaneous application: 42 % (w/w)
No. with + reactions:
19
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Intradermal injections: 0.1 % (w/v), Epicutaneous application: 1 % (w/w)
No. with + reactions:
20
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Intradermal injections: 0.1 % (w/v), Epicutaneous application: 1 % (w/w)
No. with + reactions:
20
Total no. in group:
20
Key result
Reading:
other: 3nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
Intradermal injections: 0.1 % (w/v), Epicutaneous application: 1 % (w/w)
No. with + reactions:
20
Total no. in group:
20
Group:
negative control
Remarks on result:
not measured/tested
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test item was determined to be a skin sensitiser.
Executive summary:

A Magnusson's "Maximization test" was performed in female guinea pigs to determine the skin sensitising potential of the test item. The test was performed with 40 animals, 20 animals were treated with the test item and 20 animals were treated with the positive control substance 2,4-dinitrochlorobenzene. For intradermal induction three pairs of intradermal injection were made [1) Freund's Complete Adjuvant emulsion, 2) test item without adjuvant, 3) Mixture of Freund's Complete Adjuvant and test item]. Six day after the injections the entire area of the sites was clipped and 10% sodium lauryl sulfate was massaged into the clipped area without bandaging. After 24 hours, the test and control compounds were spread over a patch of filter paper (2 cm x 4 cm) in a thick even layer and applied to the corresponding areas of the skin of the guinea pigs for 48 hours.The challenge application was performed on the shaved area of the flank after 2 weeks of the topical application. The test agents were applied on 2 x 2 cm patches of filter papers which were contacted for 24 hours under a sealed dressing. The challenge sites were evaluated at 24, 48 and 72 hours after the removal of the patches by a 4-point scale. Positive reactions were observed in guinea pigs treated with the positive control or the test item. Therefore, the test item was determined to be a skin sensitiser.

 

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A Magnusson's "Maximization test" was performed in female guinea pigs to determine the skin sensitising potential of the test item. The test was performed with 40 animals, 20 animals were treated with the test item and 20 animals were treated with the positive control substance 2,4-dinitrochlorobenzene. For intradermal induction three pairs of intradermal injection were made 1) Freund's Complete Adjuvant emulsion, 2) test item without adjuvant, 3) Mixture of Freund's Complete Adjuvant and test item]. Six day after the injections the entire area of the sites was clipped and 10% sodium lauryl sulfate was massaged into the clipped area without bandaging. After 24 hours, the test and control compounds were spread over a patch of filter paper (2 cm x 4 cm) in a thick even layer and applied to the corresponding areas of the skin of the guinea pigs for 48 hours.The challenge application was performed on the shaved area of the flank after 2 weeks of the topical application. The test agents were applied on 2 x 2 cm patches of filter papers which were contacted for 24 hours under a sealed dressing. After challenge the test sites were evaluated and scored at 24, 48 and 72 hours by a 4-point scale. Positive reactions were observed in guinea pigs treated with the positive control or the test item. Therefore, the test item was determined to be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008


The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is considered to be classified for skin sensitization Cat. 1 (H317) under Regulation (EC) No 1272/2008, as amended for the seventeenth time in Regulation (EU) 2021/849. The substance is listed in Annex VI of the CLP regulation and harmonized classified for skin sensitization Cat.1 (H317) under Regulation (EC) No 1272/2008, as amended for the seventeenth time in Regulation (EU) 2021/849.