Registration Dossier
Registration Dossier
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EC number: 253-211-7 | CAS number: 36788-39-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2012
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:
- 7-[2-(2-hydroxymethylethoxy)methylethoxy]tetramethyl-3,6,8,11-tetraoxa-7-phosphatridecane-1,13-diol
- EC Number:
- 253-211-7
- EC Name:
- 7-[2-(2-hydroxymethylethoxy)methylethoxy]tetramethyl-3,6,8,11-tetraoxa-7-phosphatridecane-1,13-diol
- Cas Number:
- 36788-39-3
- Molecular formula:
- C18H39O9P
- IUPAC Name:
- 7-[2-(2-hydroxymethylethoxy)methylethoxy]tetramethyl-3,6,8,11-tetraoxa-7-phosphatridecane-1,13-diol
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Animals:20 females (nulliparous and non-pregnant), five females per group. Young adult animals (approx. 8 weeks old) were selected. Body weight variation was within +/- 20% of the sex mean.Conditions:Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study. AccommodationAnimals were group housed in labeled Makrolon cages (MIII type; height 18 cm) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France). Paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom) and shelters (disposable paper corner home, MCORN 404, Datesand Ltd, USA) were supplied as cage-enrichment. The acclimatization period was at least 5 days before the start of treatment under laboratory conditions. On Day 6, the animals were group housed in Makrolon MII type cages with a sheet of paper instead of sawdust and cage enrichment.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 5, 10, 25% concentrations
- No. of animals per dose:
- 5 female rats per dose
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 8
- Test group / Remarks:
- 25%
- Parameter:
- EC3
- Value:
- 14
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The SI values calculated for the substance concentrations 5, 10 and 25% were 1.2, 1.1 and 8.0 respectively. An EC3 value of 14.1% was calculated using linear interpolation.
- Executive summary:
The SI values calculated for the substance concentrations 5, 10 and 25% were 1.2, 1.1 and 8.0 respectively. An EC3 value of 14.1% was calculated using linear interpolation.
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