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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EC Directive 67/548/EEC, B.6 OECD Guideline no. 406: Skin Sensitisation Maximization test.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
427-230-8
EC Name:
-
Cas Number:
5571-36-8
Molecular formula:
C20H26O3
IUPAC Name:
(3bS,11aS)-11a-methyl-1,2,3,3a,3b,4,5,6,8,9,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolan]-1-one

In vivo test system

Test animals

Species:
other: Dunkin Hartley strain, albino guinea pig (SPF-Quality)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal (day 1): The scapular region was clipped and
three pairs of intradermal injection (0.1 ml/site) were made
in this area as follows:
A) A 1:1 w/w mixture of freunds' Complete Adjuvant with
water for injection;
B) The test substance at a 0.2% concentration;
C) A 1:1 w/w mixture of the test substance, at twice the
concentration used in B) and Freunds' Complete Adjuvant
Epidermal (Day 7): The scapular area between the injection
sites was clipped and subsequently rubbed with 10%
sodium-dodecyl-sulfate (SDS) in vaseline using a spatula.
This concentration of SDS provokes a mild inflammatory
reaction.
11
Epidermal (Day 8): The 10% SDS treated area between the
injection sites was treated with 0.5 ml of a 50% test
substance concentration using a Metalline patch (2*3 cm)
mounted on Medical tape, which was held in place with
Micropore tape and subsequently Coban elastic bandage.
The dressing was removed after 48 hours exposure and the
skin cleaned of residual test substance.
Concentration of test material and vehicle used for each challenge:
50% and 0% test substance in propylene glycol.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal (day 1): The scapular region was clipped and
three pairs of intradermal injection (0.1 ml/site) were made
in this area as follows:
A) A 1:1 w/w mixture of freunds' Complete Adjuvant with
water for injection;
B) The test substance at a 0.2% concentration;
C) A 1:1 w/w mixture of the test substance, at twice the
concentration used in B) and Freunds' Complete Adjuvant
Epidermal (Day 7): The scapular area between the injection
sites was clipped and subsequently rubbed with 10%
sodium-dodecyl-sulfate (SDS) in vaseline using a spatula.
This concentration of SDS provokes a mild inflammatory
reaction.
11
Epidermal (Day 8): The 10% SDS treated area between the
injection sites was treated with 0.5 ml of a 50% test
substance concentration using a Metalline patch (2*3 cm)
mounted on Medical tape, which was held in place with
Micropore tape and subsequently Coban elastic bandage.
The dressing was removed after 48 hours exposure and the
skin cleaned of residual test substance.
Concentration of test material and vehicle used for each challenge:
50% and 0% test substance in propylene glycol.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Signs of irritation during induction: Intradermal injections Test animals on day 3 - injection A): Well defined to severe erythema; - injection B): Signs of necrosis 5-6 mm in diameter; - injection C): Signs of necrosis 4-6 mm in diameter. Control animals on Day 3 - injection A): Well defined to severe erythema - injection B) (only vehicle): Signs of necrosis, 5-6 mm in diameter; - injection C) (FCA with vehicle): Signs of necrosis 5-6 mm in diameter. Epidermal injections Test animals on Day 10 - No visible erythema to discrete or patchy erythema Control animals on Day 10 12 - No visible erythema The reactions noted in the experimental animals after the epidermal induction exposure were considered to be enhanced by the SDS treatment. Evidence of sensitisation of each challenge concentration: No skin reactions were evident after the challenge exposure in the experimental and control animals. No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study. Other observations: Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

Applicant's summary and conclusion

Interpretation of results:
other: not classified