Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was not performed according to GLP; however, test parameters were well documented, thus data are scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The test has been conducted prior to the current OECD guideline.
GLP compliance:
no
Type of study:
open epicutaneous test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Material: GIV 3-1094

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: in a suitable vehicule (ethanol, acetone, H2O, vaseline or PEG
Concentration / amount:
3, 10, 30 and 100% (undiluted)
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: in a suitable vehicule (ethanol, acetone, H2O, vaseline or PEG
Concentration / amount:
3, 10, 30 and 100% (undiluted)
No. of animals per dose:
one to six experimental groups and one control group of 6 to 8 guinea pigs are used

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Day 21 and 35
Hours after challenge:
24
Group:
other: treated groups and control group
Dose level:
3%, 10%, 30% and 100%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading:
Reading:
other: Day 21 and 35
Hours after challenge:
48
Group:
other: treated groups and control group
Dose level:
3%, 10%, 30% and 100%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading:
Reading:
other: Day 21 and 35
Hours after challenge:
72
Group:
other: treated groups and control group
Dose level:
3%, 10%, 30% and 100%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
Epicutaneous challenge tests are negative. GIV 3-1094 does not sensitize the Guinea pigs in OET.