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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Not sensitising in the guinea pig (Buehler assay)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
Buehler Test
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
predates REACH regulation and subsequent related regulations concerning preference for LLNA for in vivo testing
Specific details on test material used for the study:
Source: Nouplaz TOTM(Tenneco Chemicals, Inc.) Purity: 98.95%
Species:
guinea pig
Strain:
other: Albino Guinea Pig
Sex:
male
Details on test animals and environmental conditions:
Temperature - 70 ± 2 degree F
Relative Humidity - 45% ± 5%
Light - 12 hour light/dark cycle
Diet - Charless River Guinea Pig Furmula and tap water are provided ad libitum. Based on our current knowledge no contaminants were
known to be in this diet or water that might be expected to interfere with the objectives of the study.
Caging - Stainless steel with elevated wire mesh flooring 5 guinea pigs/cage
Bedding - Deodorized Animal Cage Board (DACB)
Shepherd Products Company
Kalamazoo, Michigan 49005
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL
Day(s)/duration:
1
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL
Day(s)/duration:
1
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml
Day(s)/duration:
1
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Details on study design:
A 0.5 mL portion of material was applied to the intact skin test site on the guinea pigs. A gauze patch was placed over the treated area and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place. After a 24 hour contact period the patch was removed and the animals were allowed to rest for one day. Following this rest period another application was applied to the same skin site using a fresh sample. After the tenth application the animals were rested for a two week period. At the termination of the rest period a challenge application was put on skin sites differing from the original test sites. The challenge application remained on for 24 hours. The sites were examined for reaction using the Draize method of scoring to grade reactions.
Key result
Reading:
other: Readings 1-10
Group:
test chemical
Dose level:
0.5 mL/induction
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Interpretation of results:
GHS criteria not met
Conclusions:
The analogue test substance was evaluated for skin sensitisation potential according to OECD Guideline 406 using a Buehler Test on guinea pigs. The test substance did not produce skin sensitisation in any animal. These data are applicable to the registered (target) substance; classification criteria are not met and the substance is not classified.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance is evaluated as non-sensiting in the Buehler test in guinea pigs. The data do not meet the criteria for classification according to Regulation EC No. 1272/2008.