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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to the draft RAR (EU, 2008), study conducted to current regulatory guidelines

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The testing of the skin-sensitising effect of Chloroparaffin 40G (containing 1% stabiliser B74) in the guinea pig
Author:
Murmann P
Year:
1988
Bibliographic source:
Huls AG Report No. 1336. Huls AG, Marl, Germany
Reference Type:
secondary source
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: According to the draft RAR (EU, 2008), study conducted to current regulatory guidelines
Deviations:
not specified
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing data already available using another assay.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Chloroparaffin 40G
- Substance type: technical product
- Impurities (identity and concentrations): 1% epoxy stabiliser B74
- Composition of test material, percentage of components: C14-17 chlorinated paraffin; 40% chlorination
- Isomers composition: No data

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and topical
Vehicle:
maize oil
Concentration / amount:
20% in maize oil for intradermal induction; undiluted for topical induction. Undiluted for first challenge, 50% in maize oil for second challenge
Challengeopen allclose all
Route:
other: presumably topical
Vehicle:
maize oil
Concentration / amount:
20% in maize oil for intradermal induction; undiluted for topical induction. Undiluted for first challenge, 50% in maize oil for second challenge
No. of animals per dose:
20
Details on study design:
Skin treated with Freund's Adjuvant prior to topical induction
Challenge controls:
10 (controls); Undiluted for first challenge, 50% in maize oil for second challenge
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
reaction score of 1; C14-17 chlorinated paraffin (40% chlorination)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: reaction score of 1; C14-17 chlorinated paraffin (40% chlorination).
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
undiluted
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
reaction score of 3; C14-17 chlorinated paraffin (40% chlorination)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: undiluted. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: reaction score of 3; C14-17 chlorinated paraffin (40% chlorination).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No skin sensitisation reactions were seen in a guinea pig maximization test with Chloroparaffin 40G (a C14-17 chlorinated parrafin; 40% chlorinated)
Executive summary:

In a guinea pig maximization test, a group of 20 animals were induced with an intradermal injection of 20% Chloroparaffin 40G (a C14-17 chlorinated paraffin; 40% chlorination, containing 1% epoxy stabilizer) in maize oil followed by a topical dose of the undiluted material. The initial challenge was with the undiluted test material and the second challenge with a 50% solution in maize oil. Ten guinea pigs were used as challenge controls.

At topical induction, the undiluted material produced "an intense, sometimes haemorrhagic, purulent inflammation", most likely associated with pre-treatment with Freund's Adjuvant. Following initial challenge, one test and one control animal showed a reaction at 48 h, with a score of 1 and 3, respectively. No skin response was seen after the second challenge.

Under the conditions of this study, Chloroparaffin 40G would not be classified as a skin sensitiser according to EU CLP or DSD regulations.