Registration Dossier
Registration Dossier
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EC number: 942-177-5 | 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:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Plastic, waste, pyrolized, distn., oil
- Molecular formula:
- Not applicable
- IUPAC Name:
- Plastic, waste, pyrolized, distn., oil
- Test material form:
- liquid
- Details on test material:
- Substance manufactured by the lead registrant according to the third compostion included in the registration dossier of Plastic, waste, pyrolized, fractionation bottoms (Raw Diesel)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
AnLab Prague, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
8-12 weeks
- Weight at study initiation:
- Housing:
polycarbonate IVC cages (5 animals per cage) in a room equipped with cenrtal air-conditoning.
- Diet (e.g. ad libitum):
ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
5 days
- Indication of any skin lesions:
No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature
- Humidity (%): 30%
- 70%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- No. of animals per dose:
- 5 animals per concentration
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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