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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:
January 17, 1995 - February 7, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD-Guideline 406, "Skin Sensibilization", July 7, 1992. "Guinea Pig Maximisation Test" Good Laboratory Practice (OECD-Principles of Good Laboratory Pratice, Enviromnent Monograph No. 45, Paris, 1992)
Cross-reference
Reason / purpose for cross-reference:
reference to same 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)
GLP compliance:
yes (incl. QA statement)
Remarks:
Authorisation letter are attached in "Attached full study report"
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
Animal maintenance:
Hygiene: improved hygienic conditions
Room numer: EH1-19
Room temperature: average of c.a. 22°C
Relative humidity: average of 40%
Control of room temp. and rel. humidity: continuous control and recording
Air excange: ca. 12/h
Light: only artificial light from 6.00 a.m. tio 6.00 p.m.
Cages: Makrolon type III (23 cm x 39 cm x 15cm) with wire mesh lids, single caging.
Feed: Altromin Standard Diet No. 3022, ad libitum, offered in stainless steel containers. Analysis of feed for ingredients and contaminants are performed radomly by Altromin GmbH, D-32791 Lage
Bedding material: wood chip (aspen) from FINN TAPVEIKY, SF-73600 Kaavi Reduction of microorganism by autoclaving.
Water: tap water, acidified with HCl to pH=3, offered in Makrolom bottles with stainless steel canules, ad libitum.
Identification of the animals: numbers tattooed in the pinna of the right ear.
Acclimatisation: c.a. 2 weeks.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Physiological saline for the intratermal induction exposure. Withe perolatum (OAB9) or the epicutaneus induction exposure and for the callenge exposure
Concentration / amount:
5% in physiological saline for the intratermal induction
40% in white petrolatum for epicutaneous induction
37.5% in white petrolatum for the challenge exposure
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Physiological saline for the intratermal induction exposure. Withe perolatum (OAB9) or the epicutaneus induction exposure and for the callenge exposure
Concentration / amount:
5% in physiological saline for the intratermal induction
40% in white petrolatum for epicutaneous induction
37.5% in white petrolatum for the challenge exposure
No. of animals per dose:
10
Positive control substance(s):
yes
Remarks:
1,4-phenylenediamine

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
37.5%
No. with + reactions:
9
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 37.5%. No with. + reactions: 9.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
37.5%
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: 37.5%. No with. + reactions: 7.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
37.5%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 37.5%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
37.5%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 37.5%. No with. + reactions: 1.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Conclusions:
The net rate sensitized test substance group animal was obtained by subtracting the percentage of positively reaction control group animals from the percentage of sensitized test substance group animals and was therefore 35% (45% minus 10%).
According to EC-Guideline 93/21 (April 27 , 1993), the test substance “D-VAL-DANE” should be labelled with “R43 May cause sensitization by skin contact”