Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed in 1978 before the development and validation of the LLNA.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Chlorendic anhydride- Analytical purity: 93.81%- Lot/batch No.: 3-12-206

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Source: - Age at study initiation: - Weight at study initiation: 418 to 587 g- Housing: Suspended metal cages- Diet: Purina Rabbit Chow, ad libitum and cabbage 3 times per week.- Water: ad libitum- Acclimation period: 21 daysENVIRONMENTAL CONDITIONS- Temperature (°C): - Humidity (%): - Air changes (per hr): - Photoperiod (hrs dark / hrs light):IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Sodium chloride solution.
Concentration / amount:
0.9%
Challengeopen allclose all
Route:
intradermal
Vehicle:
other: Sodium chloride solution.
Concentration / amount:
0.9%
No. of animals per dose:
8
Positive control substance(s):
yes
Remarks:
2,4-Dinitro-1-Chlorobenzene

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 ml
No. with + reactions:
4
Total no. in group:
4
Clinical observations:
Wheal and flare
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 ml. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Wheal and flare.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 ml
No. with + reactions:
4
Total no. in group:
4
Clinical observations:
Wheal and flare
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 ml. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Wheal and flare.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 ml
No. with + reactions:
5
Total no. in group:
8
Clinical observations:
Wheal and flare
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 5.0. Total no. in groups: 8.0. Clinical observations: Wheal and flare.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1 ml
No. with + reactions:
2
Total no. in group:
8
Clinical observations:
Wheal and flare
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 2.0. Total no. in groups: 8.0. Clinical observations: Wheal and flare.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Based upon the results obtained the test compound would be considered a possible sensitizing agent in man.