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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: conforms to guideline of the time & GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
yellow powder
purity: 99,1 %
Stability in ethanol/water (vehicle): > 6h

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
Weigt range: 293 - 345g; mean: 313g
controlled climate: ca. 20 C, 50 % humidity
food & water : ad libitum

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: induction: ethanol/water (4/1); challenge: acetone
Concentration / amount:
first & second induction;: 0,5 %
third induction: 0,1 %
challenge: 0,1 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: induction: ethanol/water (4/1); challenge: acetone
Concentration / amount:
first & second induction;: 0,5 %
third induction: 0,1 %
challenge: 0,1 %
No. of animals per dose:
Control: 10
Treatment: 20
Positive control substance(s):
not required
Remarks:
This was a positive cotrol test

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
skin yellow discolored
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: 10.0. Clinical observations: skin yellow discolored.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
skin yellow discolored
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: 10.0. Clinical observations: skin yellow discolored.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0,1 %
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
skin yellow discolored
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,1 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: skin yellow discolored.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0,1 %
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
skin yellow discolored
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,1 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: skin yellow discolored.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
1-chloro-2,4-dinitrobenzene was sensitising in guinea pigs after treatemnt using the Buehler test method