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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Remarks:
in vivo
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Study period:
From January 24, 1994 to March 24, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant and conducted according to internationally accepted testing guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Available test with good report
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Weight at study initiation: between 300 to 433 g.- Housing: The animals were housed individually in Macrolon cages (Type 3)- Diet: The animals received ad libitum standard guinea pig pellets -NAFAG No. 845- Water: ad libitumENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3 °C- Humidity (%): 30 to 70 %- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 % of test item in vaseline
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % of test item in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 % of test item in vaseline
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % of test item in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
other: -Not classified according to the CLP Regulation (EC n. 1272/2008)
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test article is considered to be a non sensitizer.
Executive summary:

To assess the allergenic potential of test item in albino guinea pigs the Maximization-Test of B. Magnusson and A.M. Kligman was used. Five male and five female were used as control group and 10 male and 10 female were used as test group.

RESULTS

Under the experimental conditions employed, none of the animals of the test group showed skin reactions 24 and 48 hours after removing

the dressings. Therefore the test article is considered to be a non sensitizer  According to the CLP Regulation (EC n. 1272/2008).

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

Experiment was made in 1994 conducted according to the guideline OECD 406 and EU method B.6 and the purity was 90 %

Five male and five female were used as control group and 10 male and 10 female were used as test group.

The highest test article concentration used for challenge application was 50 % in vaseline.

Erythema reactions were observed with 20, 30, and 50 % of test item in vaseline. No deaths occurred.

In this study 0 % of the animals were positive after treatment with the highest test substance concentration of 50 % in vaseline. Therefore the test article is considered to be a non sensitizer.


Migrated from Short description of key information:
The test article is considered to be a non sensitizer.

Justification for selection of skin sensitisation endpoint:
available study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) 3.4.1.2 Skin sensitiser means a substance that will lead to an allergic response following skin contact.

The substance is not capable to produce positive reactions after treatment with the highest test substance concentration.

The test article is considered to be a non sensitizer and no classification is warranted.