Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
other: extracted from ECHA database
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration and vehicle used at induction:
a) intradermal:
- 1% (w/v) in arachis oil BP
- 1% (w/v) in Freund's Complete Adjuvant plus arachis oil BP in ration 1:1
b) Topical induction:
- 25% (W/v) in arachis oil BP

Concentration of test material and vehicle used for each challenge:
5% (w/v) in arachis oil BP.
Challenge
Concentration / amount:
Concentration and vehicle used at induction:
a) intradermal:
- 1% (w/v) in arachis oil BP
- 1% (w/v) in Freund's Complete Adjuvant plus arachis oil BP in ration 1:1
b) Topical induction:
- 25% (W/v) in arachis oil BP

Concentration of test material and vehicle used for each challenge:
5% (w/v) in arachis oil BP.
No. of animals per dose:
20
negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
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: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
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: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Signs of irritation during induction:

reactions of grade 2 were noted at 14 test skin sites 1 hr after patch removal and 8 of grade 1 at 24 hr.

However, large areas of pale grey/green-coloured necrosis prevented accurate evaluation of erythema during induction at several skin sites at both the 1 -hr and 24 -hr observations. Other adverse dermal reactions noted were small scattered areas of pale grey/green necrosis, bleeding, small superficial scabs, hardened dark brown-coloured scabs, dried blood and desquamation.

Evidence of sensitisation of each challenge concentration: 1/18

One test group animal was found dead on day 23 and another was killed for humane reasons on day 23 owing to rectal prolapse. The absence of these animals was considered not to affect the integrity of the study.

Small scattered areas of dermal necrosis, accompanied by thickening of the skin, were noted at the test material challenge site of one control group animal at the 24 and 48 hr observations. A small scab was also noted at the test material site of one other control animal at these times. These reactions were attributed to irritancy of the test material.

No skin reaction were noted at the test material challenge sites of any other test or control group animal or at any vehicle control sites of the test and control group animals.

Bodyweight gains of animal in the test group were comparable to those in the control group.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information