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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
see read-across justifocation in section Chapter 13
Reason / purpose for cross-reference:
read-across source
Positive control results:
There were positive control results
Key result
Reading:
other: Challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25% w/v
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25% w/v. No with. + reactions: 6.0. Total no. in groups: 20.0.
Key result
Reading:
other: Challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25% w/v
No. with + reactions:
9
Total no. in group:
20
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25% w/v. No with. + reactions: 9.0. Total no. in groups: 20.0.
Key result
Reading:
other: Challenge
Hours after challenge:
24
Group:
other: Challenge control
Dose level:
25% w/v
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: other: Challenge control. Dose level: 25% w/v. No with. + reactions: 2.0. Total no. in groups: 10.0.
Key result
Reading:
other: Challenge
Hours after challenge:
48
Group:
other: Challenge Control
Dose level:
25% w/v
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: other: Challenge Control. Dose level: 25% w/v. No with. + reactions: 1.0. Total no. in groups: 10.0.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
20% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 20% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
20% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 20% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: rechallenge control
Dose level:
20% w/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: rechallenge control. Dose level: 20% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: rechallenge control
Dose level:
20% w/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: rechallenge control. Dose level: 20% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
10% w/v
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10% w/v. No with. + reactions: 2.0. Total no. in groups: 20.0.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
10% w/v
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10% w/v. No with. + reactions: 1.0. Total no. in groups: 20.0.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: rechallenge control
Dose level:
10% w/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: rechallenge control. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
other: rechallenge control
Dose level:
10% w/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: rechallenge control. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test there is no significant difference in the dermal response after the challenge or rechallenge applications of the test material. The test material was determined to be not sensitising and therefore does not require classification according to Regulation (EC) 1272/2008.
Executive summary:

In a GLP compliant Buehler test, the skin sensitisation potential was assessed according to OECD guideline 406. Twenty Guinea pigs were exposed to the test material first using three induction exposures at 50 and 40 % w/v, then in a challenge and rechallenge exposure at 25, 20 and 10 % w/v. None of the test animals’ displayed a dermal reaction greater than the challenge control during the challenge or rechallenge. Under the conditions of the test, the test material was determined to be not sensitising and therefore does not require classification according to Regulation (EC) 1272/2008.

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

The key study (Rodabaugh, 2001) is a GLP compliant study which was performed in line with standardised guidelines with a sufficient level of detail to assess the quality of the study. The skin sensitisation was determined in vivo according to the Buehler test. Under the conditions of the test none of the animals displayed a dermal reaction greater than the control in either the challenge or rechallenge, thus the test material was determined to be non-sensitising. The study was performed to a good standard and was assigned a reliability score of 1 using the principles for assessing data quality as set out in Klimisch (1997).


Migrated from Short description of key information:
The potential for hydrocarbon waxes to cause skin sensitisation was determined according to a GLP compliant study (Rodabaugh, 2001) performed according to the standardised guidelines OCED 406 and EPA OPPTS 870.2600.

Justification for classification or non-classification

SKIN SENSITISATION

The guinea pig skin sensitisation study indicates that the test material is a non sensitizer and exposure does not result in any classifiable effects. Therefore the material does not require classification in line with Regulation (EC) 1272/2008.