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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation (in vivo, OECD 406, GPMT): 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:
1994-02-01 to 1994-02-25
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:
1981
Deviations:
yes
Remarks:
non-irritant 50% aqueous solution used for induction
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
yes
Remarks:
non-irritant 50% aqueous solution used for induction
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No. 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.
Species:
guinea pig
Strain:
other: Hsd/Win: DH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Age at study initiation: 9 weeks (males and females)
- Weight at study initiation: 493 - 533 g (males); 419 - 469 g (females)
- Housing: individually in Macrolon cages type IV
- Diet: standard diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0 - 19.5
- Humidity (%): 52 - 70
- Photoperiod: 12 hrs dark / 12 hrs light
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1%
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
50%
Day(s)/duration:
48 h
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
30%
Day(s)/duration:
24 h
No. of animals per dose:
control group: 6 (3 m / 3 f) animals (2 control groups used)
treatment group: 10 (5 m / 5 f) animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE

intracutaneous application
- No. of exposures: 1
- Test groups: 2 x Freund's Complete Adjuvant (FCA)/physiological saline solution (1:1); 2 x test substance solution; 2 x test substance solution/ FCA (1:1)
- Control groups: 2 x FCA/physiological saline solution (1:1); 2 x 0.9% physiological saline solution; 2 x 0.9% physiological saline solution/ FCA (1:1)
- Application site: scapular area
- Site: area of 4 x 6 cm of the scapular region
- Concentration: 1%
- Application volume: 0.1 mL

epicutaneous application
- No. of exposures: 1
- Test group: test substance in 0.9 % physiological saline solution
- Control groups: 0.9 % physiological saline solution
- Application site: scapular area
- Site: vehicle right flank; test substance left flank
- Duration: 48 h
- Concentration: 50%
- Application volume: 1.0 mL

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 24 h
- Test group: test substance in 0.9 % physiological saline solution
- Control groups: test substance in 0.9 % physiological saline solution
- Site: vehicle right flank; test substance left flank
- Concentrations: 30%
- Application volume: 0.2 mL
- Evaluation (h after challenge): 24 and 48
Positive control substance(s):
yes
Remarks:
1,4-phenylenediamine in a separate experiment (study no. 898470, Nov. 1993)
Positive control results:
The proof of the sensitivity of the Guinea Pig strain was tested in a separate investigation (study no. 898470, Nov. 1993) with 1,4-phenylenediamine as positive control substance. All animals showed signs of sensitisation.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
12
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
12
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Group:
positive control
Remarks on result:
other: tested in separate experiment (study no. 898470, Nov. 1993)
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions used in the Guinea Pig Maximisation Test (GPMT) the test substance showed no sensitising potential.
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A Guinea Pig Maximisation Test (93-0103-DNT) was conducted to assess the skin sensitising properties of the test substance . The study was performed in accordance with OECD guideline 406 and in compliance with GLP. Five male and 5 female guinea pigs were induced with a primary intradermal injection and a secondary topical induction on study Days 1 and 7, followed by a challenge with topical application on Day 22.

For the primary induction, 1% test substance formulation in vehicle (physiological saline), 1% test substance formulation in Freund’s Complete Adjuvant (FCA) and FCA were intradermally injected into the clipped scapular region. As the test substance did not exhibit skin irritating properties, the animals were pre-treated with 10% sodium dodecyl sulfate (SDS) one day before epicutaneous application, on Day 6. Seven days after the first induction, on Day 7, an epicutaneous induction with 50% test substance was performed using an occlusive dressing for 48 h. A group of 3 male and 3 female guinea pigs was treated in the same manner with the vehicle only and served as the control group.

Three weeks after the induction procedure the animals were challenged by occluded topical administration of 50% test substance in physiological saline for 24 h. Skin reactions were evaluated 24 and 48 h after patch removal.

The capability of the test system and the strain of guinea pigs to respond to skin sensitising agents was demonstrated in a separate study (study No. 898470, Nov. 1993), in which 1,4-phenylene diamine was used as positive control.

The challenge application of the test substance did not induce any skin reaction in any animal at any reading time point. Based on the results of the study, the test substance 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 according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.

No classification for skin sensitisation is warranted according to the criteria of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations.