Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to the final RAR (EU, 2000), this was a well-conducted study, performed according to modern protocols and using suitable induction regimes; only basic data given in expert review

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
2000
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Magnusson and Kligman method using guinea pigs: intradermal injection of Freund's complete adjuvant; dermal induction with test substance (a C10-13 chlorinated paraffin; assumed to be about 50% chlorination); dermal challenge with test substance; assessment of reactions and sensitisation potential of test substance.
GLP compliance:
not specified
Type of study:
other: Magnusson and Kligman test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in secondary source): a C10-13 paraffin (assumed to be approximately 50% chlorinated)
- Substance type: technical product
- Physical state: probably liquid
- Analytical purity: no data
- Impurities (identity and concentrations): 1% stabiliser (Edenol B 74)
- Composition of test material, percentage of components: C10-13 chlorinated paraffin (approximately 50% chlorinated)
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: 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 in citing secondary source.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: Epicutaneous; type of covering (or lack thereof) not specified.
Vehicle:
unchanged (no vehicle)
Concentration / amount:
No data
Challengeopen allclose all
Route:
other: Epicutaneous; type of covering (or lack thereof) not specified.
Vehicle:
unchanged (no vehicle)
Concentration / amount:
No data
No. of animals per dose:
20 treated animals. Number of controls not specified.
Details on study design:
Sensitization potential in guinea pigs was evaluated using the Magnusson and Kligman method (which involves injection of Freund's complete adjuvant, followed by dermal induction and then dermal challenge with the test substance). No data on induction exposure was given; animals were challenged with undiluted material, and then rechallenged one week later.
Challenge controls:
Yes, apparently at 24 h and 1 wk. No further data given
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:
24
Group:
test group
Dose level:
Undiluted
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
2 animals showed marked diffuse redness; one showed slight redness and dryness at 24 h
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Undiluted. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: 2 animals showed marked diffuse redness; one showed slight redness and dryness at 24 h.
Reading:
rechallenge
Hours after challenge:
168
Group:
test group
Dose level:
Undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 168.0. Group: test group. Dose level: Undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Not relevant
No. with + reactions:
0
Clinical observations:
None; number of controls not specified.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Not relevant. No with. + reactions: 0.0. Clinical observations: None; number of controls not specified..
Reading:
rechallenge
Hours after challenge:
168
Group:
negative control
Dose level:
Not relevant
No. with + reactions:
0
Clinical observations:
None; number of controls not specified.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 168.0. Group: negative control. Dose level: Not relevant. No with. + reactions: 0.0. Clinical observations: None; number of controls not specified..

Any other information on results incl. tables

Number of controls not specified.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
A C10-13 chlorinated paraffin (assumed to be approximately 50% chlorinated) was not sensitising to the skin of 20 guinea pigs when tested using the method of Magnusson and Kligman (involving dermal induction of test animals after administration of Freund's complete adjuvant, followed by dermal challenge and, one week later, rechallenge with the test substance).
Executive summary:

The potential of a C10-13 chlorinated paraffin (assumed to be approximately 50% chlorinated) to produce skin sensitisation in guinea pigs has been assessed using the Magnusson and Kligman method (which involves injection of Freund's complete adjuvant, followed by dermal induction and then dermal challenge with the test substance). In the study (reported in the final RAR (EU, 2000) as well-conducted and performed according to modern protocols and using suitable induction times) animals were challenged with undiluted C10 -13 paraffin (50% chlorinated) and evaluated after 24 hours; 2/20 showed marked diffuse redness and 1/20 showed slight redness and dryness. When the same animals were re-challenged 1 week later, no skin reactions were seen. No skin reactions were seen in the control group.

In conclusion, the paraffin tested did not induce skin sensitisation in guinea pigs, and no classification or labelling with respect to skin sensitisation would be required under EU CLP or DSD regulations.