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Diss Factsheets

Administrative data

Description of key information

In a study similar to OECD TG 406 performed on guinea-pigs the substance is not to be classified as skin sensitizer (reference 7.4.1 -1).

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
no guideline available
Guideline:
other: Klecak G: Chapter 9 in "Advances in Modern Toxicology", Vol. 4, Dermatology and Pharmacology (ed. Marzulli and Maibach), 1977
Principles of method if other than guideline:
Guinea pigs are used for this test. During induction, the test item was topically applied to the shaved skin of the back of the animals once daily for a time period of 21 days. Challenges were performed on days 22 (Challenge I) and on day 36 (Challenge II). After challenge the animals were examined for skin reactions 24, 48 and 72 hours after administration.
GLP compliance:
yes
Type of study:
open epicutaneous test
Justification for non-LLNA method:
The test was conducted prior REACH came in force.
Species:
guinea pig
Strain:
other: Iva:PDH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 5 weeks
- Weight at study initiation: Mean initial body weight: 335 g
- Housing: individual in Makrolon cages type IV
- Diet: ad libitum, Altromin Standard Diet
- Water: ad libitum, tap water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 27
- Humidity (%): 39 - 45
- Photoperiod (hrs dark / hrs light): 12/12


Route:
epicutaneous, open
Vehicle:
other: HPMC (hydroxypropylmethyl cellulose)
Concentration / amount:
30%
Day(s)/duration:
21 days
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: HPMC (hydroxypropylmethyl cellulose)
Concentration / amount:
3, 10 and 30%
Day(s)/duration:
Day 22
No.:
#2
Route:
epicutaneous, open
Vehicle:
other: HPMC (hydroxypropylmethyl cellulose)
Concentration / amount:
3, 10 and 30%
Day(s)/duration:
day 36
No. of animals per dose:
6
Details on study design:
RANGE FINDING TESTS: A pretest to determine the threshold concentration after single application was done with 3, 10 and 30% preparations. The high concentration of 30% did not induce skin irritation and was therefore used as test concentration.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 21 days
- Test groups: 0.1 mL of test material
- Control group: 0.1 mL af vehicle
- Site: shaven skin of the back
- Frequency of applications: daily
- Concentrations: 30% test material

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 22 and 36
- Test groups: 0.1 mL of test material
- Control group: 0.1 mL af vehicle
- Site: challenge I on left flank and challenge II on right flank
- Concentrations: 3, 10 and 30% test material preparations
- Evaluation (hr after challenge): 24,48 and 72 h

Three groups with 6 female guinea-pigs, each, were investigated: Group 1(untreated control), group 2 (vehicle control) and group 3 (treatment group). Group 3 was topically treated with 0.1 mL of 30% test material (Induction) daily for 21 days to the shaven skin of the back. Challenges were performed 1 and 15 days after the last treatment. Each animal of all 3 groups was challenged with 3 different test material concentrations (3, 10 and 30% test material preparations). Half of the untreated control animals (group 1) were treated on the first challenge and the rest on the second challenge with the test material preparations and the vehicle to exclude primary irritation. During the induction phase the animals were investigated for skin reactions daily, about 24 h after application of the test material always. After challenge they were examined 24, 48 and 72 hours after administration. The skin reactions were classified as
0 = negative/questionable
+ = positive
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no clinical effects observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no clinical effects observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no clinical effects observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no clinical effects observed
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no clinical effects observed
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no clinical effects observed
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no clinical effects observed
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no clinical effects observed
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the substance is not considered to be a skin sensitizer.
Executive summary:

The test item was tested for skin sensitizing activity in guinea pigs in the Open Epicutaneous Test (OET). Three groups with 6 female guinea pigs each were investigated: Group 1 (untreated control) and group 2 (vehicle control) were treated to exclude primary irritation. Group 3 was treated with 0.1 mL of 30% test material suspension (induction). During the induction period (21 days of daily treatment) brown discoloration was observed at the treated skin.

After the first and second challenge (performed at the flanks on days 22 and 36 of the study, respectively) with test material concentrations of 3, 10, and 30%, none of the different challenge sites in any of the guinea pigs showed a positive skin reaction. Under the experimental conditions given, the test item is classified as a non-sensitizer.

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

Based on the chemical composition of the substance a sensitising potential is considered highly unlikely. The test item was tested for skin sensitizing activity in guinea pigs in the Open Epicutaneous Test (OET) similar to OECD TG 406. Three groups with 6 female guinea pigs each were investigated: Group 1 (untreated control) and group 2 (vehicle control) were treated to exclude primary irritation. Group 3 was treated with 0.1 mL of 30% test material suspension (induction). During the induction period (21 days of daily treatment) brown discoloration was observed at the treated skin.

After the first and second challenge (performed at the flanks on days 22 and 36 of the study, respectively) with test material concentrations of 3, 10, and 30%, none of the different challenge sites in any of the guinea pigs showed a positive skin reaction. Under the experimental conditions given, the test item is classified as a non-sensitizer.


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 test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this information, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.