Registration Dossier
Registration Dossier
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EC number: 451-000-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- draft dd. 2001
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- dd. 2003
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- benzene, 1,4-bis[2-[3,5-dimethoxy-4-(1- methylpropoxy)phenyl]ethenyl]-
- Cas Number:
- 586410-55-1
- Molecular formula:
- C34 H42 O6
- IUPAC Name:
- benzene, 1,4-bis[2-[3,5-dimethoxy-4-(1- methylpropoxy)phenyl]ethenyl]-
- Details on test material:
- Read-across from CASRN586410-55-1 to the substance defined in section 1 allowed by belgian authority.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- nulliparous and non-pregnant, young adult animals (+/-10 weeks old; body weight variation +/- 20% of the sex mean)
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 5%, 25% and 50%
- No. of animals per dose:
- 5
- Details on study design:
- A preliminary irritation study was conducted in order to select the highest test substance concnetration to be used in the amin study. Starting- and subsequent concentrations for this preliminary study were taken from the series: 100% (undiluted), 50%, 25%, 10%, 5%, 2.5%, 1% and further lower cocnetrations using the same steps.
In the main study, the observation was as follows:
1. mortality/viability: twice daily
2. toxicity: at least once daily
3. body weights: on day 1 (pre-treatment) and 6
4. irritation: on day 3 (3-4 hours after treatment), the skin reactions were assessed - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The calculated EC3 value was found to be in the acceptable range of 2 and 20%.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Main study: The SI values calculated for the substance concentrations 4, 25 and 50% were 1.0, 0.7 and 0.9 respectively. There was no indication that the test substance could elicit an SI>=3.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Main study: Mean DPM/animal values for the experimental groups treated with test substance concentrations 5, 25 and 50% were 180, 114 and 160 respectively. The mean DPM/animal value for the vehicle conctrol group was 173.
Any other information on results incl. tables
1. preliminary study: no irritation was observed in any of the animals examined. based on the results, the highest test substance concentration for the main study was a 50% concentration.
2. main study:
2.1. induction phase: no irritation was observed in any of the animals examined
2.2. macroscopy: the majority of nodes were equal in size, except for some nodes of the 25 and 50% groups that were smaller in size. no other macroscopic abnormalities of the nodes were noted.
2.3. body weights: body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.
2.4. toxicity/mortality: no mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- not classified for sensitisation by skin contact (according to OECD (1998) and EU (67/548/EEC))
no obligatory labelling requirement for sensitisation by skin contact (EU (67/548/EEC))
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