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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:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study has been performed according to OECD and EC guidelines and according to GLP principles. The data relating to the identity, purity and stability of the test material are not mentioned in the test report but can be retrieved from the original NONS notification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Annex V
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
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): CETEC 2254
- Physical state: straw coloured liquid
- Analytical purity: not indicated

In vivo test system

Test animals

Species:
other: Guinea pig (Dunkin-Hartley)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Freund's Complete Adjuvant plus distilled water (1:1) 25% w/v

b) A 25% w/v formulation of the test material in arachis oil
BP

c) A 25% w/v formulation of the test material in Freund's

Complete Adjuvant

Concentration of test material and vehicle used for each challenge:
a) Topical Induction: undiluted test material

b) Topical Challenge: undiluted and 75% v/v in arachis oil
BP

c) Intradermal Induction: 25% w/v in arachis oil BP
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Freund's Complete Adjuvant plus distilled water (1:1) 25% w/v

b) A 25% w/v formulation of the test material in arachis oil
BP

c) A 25% w/v formulation of the test material in Freund's

Complete Adjuvant

Concentration of test material and vehicle used for each challenge:
a) Topical Induction: undiluted test material

b) Topical Challenge: undiluted and 75% v/v in arachis oil
BP

c) Intradermal Induction: 25% w/v in arachis oil BP
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation during induction:
Skin reactions observed after intradermal induction
presented as very slight to well defined erythema of all
test animals at 24 and 48-hour observation. Very slight
erythema as noted at the intradermal induction sites of all
control group animals at the 24-hour observation and in two
control animals at the 48-hour observation. Skin reactions
observed after topical induction presented as very slight or
well-defined erythema and an isolated incident of very
slight oedema were noted at the induction sites of five test
group animals at 24-hour observation. Bleeding from the
intradermal induction sites was noted in three test group
animals at the 1-hour observation. Residual test material
was noted at the induction sites of three test group animals
at the 1-hour observation. Very slight erythema was noted at
the treatment site of one control group animal at the 1-hour
observation. No evidence of skin irritation was noted at the
treatment sites of control group animals at the 24-hour
observation.

Evidence of sensitisation of each challenge concentration:
The test material produced a 0% (0/10) sensitisation rate.

Other observations:
None

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Not sensitising