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EC number: 618-848-0 | CAS number: 92413-47-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21.05.-14.06.1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted before the LLNA-test became mandatory.
Test material
- Reference substance name:
- 618-848-0
- EC Number:
- 618-848-0
- Cas Number:
- 92413-47-3
- Molecular formula:
- C16H28O
- IUPAC Name:
- 618-848-0
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: PDH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 6 - 8 weeks
- Housing: Healthy young guinea-pigs were allocated to individual cages. They were housed under conventional conditions in a 60 m2 room with artificial light (light phase: 6 a.m.-6 p.m.) and were allowed at least 7 days of acclimatization before the start of treatment. The cages used (MakrolonR cages type IV) had a floor area of 55 x 33 cm (1815 cm2) and a height of 20 cm, and were placed on mobile racks. The room temperature during the study period was 22 - 28 °c and the relative atmospheric humidity 33 - 60 %. Temperature and atmospheric humidity were registered by a thermo-hygrograph (Type 252, Wilhelm Lambrecht KG, Göttingen).
- Diet: Altromin Standard Diet TPF (R) 3012 (see item 7) and tap water (Südhessische Gas und Wasser AG, Darmstadt and Wasserwerk E. Merck, Darmstadt) from Makrolon drinking bottles were available to the guinea-pigs ad libitum. The diet is checked periodically by an independent and German Government approved testing laboratory ,- according to the regulations of the manufacturer. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides and antibiotics. Drinking water employed in this type of study is regularly investigated microbiologically, physico-chemically, and chemically. The analytical results show that the limits set by German regulations for animal feed and by German regulations for human drinking water have not been exceeded.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.05 g/100 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10 g/100 mL
- Day(s)/duration:
- Day 8/ 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1 g/100 mL
- Day(s)/duration:
- Day 22/ 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Two groups of 10 males and 10 females were used.
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the test system has been demonstrated with DNCB = 2,4 dinitro-1-chlorobenzene (challenge concentration 0.01 %) in another study
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
Any other information on results incl. tables
Findings in the induction phase
After intradermal injection the usual irritation seen after treatment with Freund's complete adjuvant was observed. The injection sites were swollen and red. Later necrosis and scabs were observed. Similar findings were seen with liquid paraffin. After removal of the patches redness and scales were observed at the topical application sites.
Positive reactions (percent) after challenge
Group Test Time points
material 24 h 48 h Total
1 Liquid paraffin 0/20 ( 0 %) 0/20 ( 0 % ) 0/40 (0%)
2 test item 0/20 ( 0 %) 2/20 (10 % ) 2/40 (5%)
Clinical findings and mortality
The clinical behavior of the guinea-pigs was normal during the study period. All animals survived the study period.
Body weight
The body weight development (Table 3) did not differ from that of the animals of the vehicle group. All animals survived the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not a skin sensitiser under the test conditions of this study.
- Executive summary:
Objective
The purpose of this Guinea-pig maximization test was to assess the skin sensitizing potential of the test material when applied to the skin of the animal.
This study should provide a rational basis for risk assessment to the sensitizing potential of the test item in man.
Study Design
For this purpose Induction was performed in two stages. At first the test material was intradermally injected with and without Freund's complete adjuvant. Then, after one week, the test material was topically applied under occlusive patch conditions for 48 hours. The challenge was performed two weeks later by topical application. The patches were then applied for 24 hours.
Results
induction phase:
The injection sites were swollen and red. Later necrosis and scabs were observed. Similar findings were seen with liquid paraffin. After removal of the patches redness and scales were observed at the topical application sites
after challenge:
No irritation was observed in the test group. 24 h after challenge with the test item, a barely perceptible erythema was observed in two female animals and considered as not positive. At the 48 h reading the challenge sites in two female animals were covered with scales. These reactions were evaluated as a positive skin reaction.
The total positive reaction was 5%.
Conclusion
The test material was not a skin sensitiser under the test conditions of this study.
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