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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Reference substance name:
similar substance 01
IUPAC Name:
similar substance 01

In vivo test system

Test animals

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.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.

Applicant's summary and conclusion

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).