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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
Guinea Pig
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15th June 2018 to 7th January 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Skin Sensitisation study (406) published by the Ministry of Environmental Protection of Peoples Republic of China in the year 2013
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
According to the Guidelines for the testing of chemicals "Skin Sensitisation Study" (406) published by the Ministry of Environmental Protection of People's Republic of China in the year of 2013, guinea pig is the preferred strain for the heredity characters, stability and available background data. Based on the Skin Sensitization result of positive control test item DNCB, this strain is reliable.

Test material

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
Source: Beijing Vital River Laboratory animal technology
A physical check up was carried out on all animals on arrival. Animals were acclimatised for 6 days and housed 10/12 animals in a plastic cage with corn cob bedding in Room A118. All animals were weighed and marked on the hair. Clinical observations were performed daily.
Temperature: 20-26oC
Humidity: 40-70%
Light sequence: 12 hour light / 12 hour dark
Food: Pellet rodent diet (Beijing keaoxieli Feed Co. Ltd.)
Food and water: ad libitum

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, semiocclusive
Vehicle:
other: Ethyl alcohol
Concentration / amount:
0.3g
Day(s)/duration:
6 hours
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
other: Ethyl alcohol
Concentration / amount:
0.3g
Day(s)/duration:
6 hours
No. of animals per dose:
20
Details on study design:
Animals were randomly assigned to two groups (control and treated) using Microsoft Excel 2007. There were 10 animals in the control group and 20 animals in the treated group.

0.3g of the test item was mixed with 0.3ml of the vehicle to moisten completely.

Induction phase
The left flanks of guinea pigs were clipped free of hair prior to each induction (approximately 4cm x 4cm). For the treated group, a piece of filter paper (2cm x 2cm) loaded with prepared test item was placed on the clipped area, covered with two layers of gauze and one layer of waterproof plastic film. The patch was then wrapped with non-allergenic medical adhesive tape. After 6 hours of exposure, the patch was removed and residual test item removed by cotton wool soaked in water. On days 7 and 14 after the first induction, dosing was repeated according to the above method. Animals in the control group were not given the test item and were treated according to the above method.

Challenge phase
The right flanks of the guinea pigs were clipped free of hair the day prior to challenge. (approximately 4cm x 4cm). On Day 28 after the first induction, the prepared test item was given to the control and treated animals with the above method. After 6 hours of exposure, the patch was removed and residual test item was removed using cotton wool soaked in water.

Observations
24 and 48 hours after the patch was removed in each induction the skin reactions were observed.
Inspections for moribundity/mortality were made daily.
Animals were weighed on the grouping day and at conclusion of the study.
Challenge controls:
10 animals
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene (DNCB)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Not specified
No. with + reactions:
17
Total no. in group:
20
Clinical observations:
Not documented
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Not specified
No. with + reactions:
17
Total no. in group:
20
Clinical observations:
Not documented
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.3g
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.3g
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the above results, the test item E Stage 3 intermediate was a non-sensitiser. The test result did not meet GHS criteria for skin sensitisation (BUEHLER) 
Executive summary:

The study was designed to determine the potential for E Stage 3 Intermediate to elicit a skin sensitisation reaction. The method was designed to be meet the Guidelines for the testing of chemicals 'Skin sensitisation study' (406) published by the Ministry of Environmental Protection of People's Republic of China in the year 2013. 


Thirty animals were used in the study, which included one control group (10 animals) and one treated group (20 animals). In the induction phase, for treated group on Day 0, Day 7 and Day 14, 0.3g of the test item was applied to the left flank of each animal in the treated group three times. In the challenge phase, on Day 28, 0.3g of the test item was applied to the right flank of each animal in the control and treated group. 24 and 48 hours after the patch removal in each induction, the skin reactions were observed. 24 and 48 hours after patch removal in the challenge group, the skin reactions were observed and scored. Individual animal body weights were recorded on grouping day and at conclusion of the study.


Mortality: There were no deaths or moribund during the test. 


Induction Phase: No abnormalities were found during the three times induction phase at the 24 hour observations after removing patches.


Challenge phase: No abnormalities were found in the control or treated animals observed at 24 and 48 hour observation. The score of skin reaction is 0 (0/20) for both 24 and 48 hour observation.


All animals showed expected gain in bodyweight during the study. 


Based on the above results, E Stage 3 Intermediate was a non-sensitiser. The test result did not meet GHS criteria for skin sensitisation (BUEHLER)