Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Feb-Mar 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP study, comparable to Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no clinical observation recorded
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZK 74.804
- Batch No.: 0291/1

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: liquid paraffin
Concentration / amount:
Intradermal induction: 1 %
Topical induction: 25%
Challenge: 25%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: liquid paraffin
Concentration / amount:
Intradermal induction: 1 %
Topical induction: 25%
Challenge: 25%
No. of animals per dose:
test substance group: 20
control group: 20

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
Challenge 25%
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: Challenge 25%. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
Challenge 25%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Challenge 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. No with. + reactions: 1.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Executive summary:

To determine the skin-sensitizing properties of AD-Cyanhydrin the guinea pig maximization test was performed on male and female guinea pigs. The study was conducted with the following test substance concentrations:

intradermal induction: 1%

topical induction: 25%

challenge: 25%

Since the substance was found to be not irritating previously, the treatment areas of the animals were pretreated with sodium lauryl sulfate prior to the second induction.

Under the condition of the maximization test and with respect to the evaluation criteria AD-Cyanhydrin exhibited no skin-sensitization potential.