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Diss Factsheets

Administrative data

Description of key information

Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 1917, 1786 and 2958 DPM respectively. The mean DPM/animal value for the vehicle control group was 312 DPM. The SI values calculated for the substance concentrations 25, 50 and 100% were 6.1, 5.7 and 9.5 respectively. Though there was only modest dose response across the 3 concentrations test, all of the results have SI values >3, indicating that the substance is skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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)
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.
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0, 5, 10, 25% concentrations
No. of animals per dose:
5 female rats per dose
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
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification

Substance is classified as a skin sensitiser.