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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23.10.1995 - 16.11.1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
O-benzyl-L-valine toluene-p-sulphonate
EC Number:
240-702-6
EC Name:
O-benzyl-L-valine toluene-p-sulphonate
Cas Number:
16652-76-9
Molecular formula:
C12H17NO2.C7H8O3S
IUPAC Name:
O-benzyl-L-valine toluene-p-sulphonate

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: intradermal: peanut oil, epicutaneous: vaseline
Concentration / amount:
Intradermal induction: 0.5% (w/v) in peanut oil
Epidermal induction: 50% (w/v) in vaseline
Challenge: 10% (w/v) in vaseline
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: intradermal: peanut oil, epicutaneous: vaseline
Concentration / amount:
Intradermal induction: 0.5% (w/v) in peanut oil
Epidermal induction: 50% (w/v) in vaseline
Challenge: 10% (w/v) in vaseline
No. of animals per dose:
10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%, challenge: 10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%, challenge: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 0.5 and 50%, challenge: 10%
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 0.5 and 50%, challenge: 10%. No with. + reactions: 6.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%, challenge: 10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%, challenge: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 0.5 and 50%, challenge: 10%
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 0.5 and 50%, challenge: 10%. No with. + reactions: 7.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Intradermal Induction Pretest

After duplicate testing of the test substance at concentrations of 0.5, 1, 3 and 5% in peanut oil, severe irritation was seen at the site of intradermal injection with either 1, 3 or 5% of the test article. Consequently, a concentration of 0.5% was suitable for injection, systemically well tolerated and chosen for intradermal induction in the maximisation test owing to mild to moderate skin irritating properties.

Epidermal Application Pretest

Incorporation of the test article into vaseline was limited to 50%. After duplicate testing of the test substance at concentrations of 10, 30 and 50%, irritant skin reactions were seen in animals treated with either 30 or 50% of the test article. The concentration of 10% was the highest non-irritant dose. Therefore, a concentration of 50% was selected for epidermal induction and 10% for the topical challenge.

Guinea Pia Maximisation Test

After removal of the occlusive dressing on day 10 after epidermal induction, irritation at the applicat:ion site was seen in all 20 guinea pigs of the test groups. Epidermal challenge resulted in posit:ive responses in 6 of 20 guinea pigs (1 male, 5 females) after 24 hours and in 7 of 20 (1 male, 6 females) after 48 hours, corresponding to a sensitisation rate of 35%. Very slight erythema reactions in 1 male and 1 female faded after the scoring at 24 hours and were recognised as transient irritation (false-positive reaction) based on clinical appearance and duration. Scaling erythema was recorded in 1 male and in 5 females after 48 hours. No irritant skin reactions were recorded among control animals.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: skin sens 1B, H317
DSD: Xi, R43