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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study Inition date: 21 July 2016 Study completion date: 24 August 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA): BrdU-ELISA

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
liquid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female
Details on test animals and environmental conditions:
Environmenta Conditions:
Animals were housed under standard laboratory conditions, environmentally monitored air-conditioned room with adequate fresh air supply (12 to 15 air changes per hour), room temperature 20.0 to 22.6 °C and relative humidity 48 to 67 %, with 12 hours flourescent light and 12 hours dark cycle. The temperature and relative humidity were reccorded once daily.
Housing:
A maximum of four animals were housed in a standard polypropylene cage (Size L 290 x B 220 x H 140 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water in bottle fitted with s´tainless steel sipper tube. Clean sterilized paddy husk was provided as bedding material
Feed:
Teklad Certified (2014SC) Global 14 % Protein Rodent diet - Pellet, manufactured by Envigo, was provided ad libitum to the mice throughout the experimental period
Water:
Water was provided ad libitum throughout the experimental period. Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in Aquaguard water filter with purifier was provided in plastic water bottles with stainless steel sipper tubes.

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Value:
> 1.6

Applicant's summary and conclusion

Interpretation of results:
other: Based on the results of this experiment, it was concluded, that DOTE was not a sensitizer under the experimental conditions employed. Therefore, in accordance with the OECD guideline, DOTE should be classiified as "non-sensitizer"
Conclusions:
Based on the results of this experiment, it was concluded, that DOTE was not a sensitizer under the experimental conditions employed. Therefore, in accordance with the OECD guideline, DOTE should be classiified as "non-sensitizer