Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

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:
LLNA test was also conducted (see Report 243491). Results of the LLNA test were negative. The results of this guinea pig maximazation test were positive and were therefore chosen as a key study along with the LLNA test. This study was conducted in 1995 whereas the LLNA test was conducted in 2007.

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
124495-18-7
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Name of substance: XDE-795 Technical
- Lot No.: RMM 2008
- Purity: 97.5%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: purified water
Concentration / amount:
0.1 mL of Freunds complete adjuvant (FCA)
Day(s)/duration:
single injection at least five days before topical application
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
First induction: 1% w/v
Sencond induction: 50% w/v
Day(s)/duration:
48 hours
Adequacy of induction:
highest technically applicable concentration used
Challengeopen allclose all
No.:
#1
Route:
intradermal
Vehicle:
other: purified water
Concentration / amount:
0.1 mL FCA
Day(s)/duration:
single injection at least 20 days before topical challenge
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
10, 50% w/v
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test group: 10 per sex per dose
Congrol group: 5 per sex per dose
Challenge controls:
Propylene glycol, 10 and 50% w/v test substance in propylene glycol
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% w/v
No. with + reactions:
18
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% w/v
No. with + reactions:
16
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% w/v
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% w/v
No. with + reactions:
8
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Repeated administration of the test substance caused delayed contact hypersensitivity in guinea pigs
Executive summary:

The potential of the test substance to cause delayed contact hypersensitivity in the guinea-pig was assessed by the Magnusson-Kligman Maximisation Test following OECD guideline 406.

The closely-clipped dorsa of ten male and ten female Dunkin-Hartley guinea-pigs were subject to intradermal injections of Freund’s Complete Adjuvant, 1% w/v test substance in propylene glycol and 1% w/v test substance in the adjuvant on Day 1. On Day 7, the same area was treated with sodium lauryl sulphate to enhance the dermal penetration of the following dose. On Day 8, 50% w/v test substance in propylene glycol was applied topically and the test site was covered by an occlusive dressing for 48 hours. The same induction procedures were carried out on a contemporaneous control group of five male and five female animals, except that the test material was replaced by vehicle in all doses.

On Day 22, all animals were challenged by occluded topical application of propylene glycol to the left flank and 50% w/v test substance and 10% w/v test substance in propylene glycol to two sites on the right flank. The occlusive dressings were removed on the following day and the condition of the test sites was assessed approximately 24 and 48 hours later.

Intradermal injection of 1% w/v test substance in propylene glycol caused moderate erythema, eschar and occasional pallor, while intradermal injection of 1% w/v test substance in propylene glycol in FCA caused slight or moderate erythema and pallor. Intradermal injection of FCA alone caused moderate erythema in all animals. Topical induction application of 50% w/v test substance in propylene glycol caused barely perceptible or slight erythema, exfoliation and occasional eschar.

Challenge application of 50% w/v test substance in propylene glycol gave rise to a significant response (slight erythema or a more marked reaction) in eighteen test animals and no controls. Challenge application of 10% w/v test substance in propylene glycol gave rise to a significant response in nine test animals and no controls. Challenge application of propylene glycol alone caused no significant response.

It is concluded that, under the conditions of this study, repeated administration of test substance in propylene glycol caused delayed contact hypersensitivity in guinea-pigs, and is classified as a dermal sensitizer.