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Description of key information

Key value for chemical safety assessment

Skin sensitisation

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Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
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)
Version / remarks:
2002
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2004
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
2003
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
Safety precautions: Gloves, goggles and face mask to ensure personnel health and safety.
Species:
mouse
Strain:
CBA
Remarks:
inbred, SPF-Quality
Sex:
female
Details on test animals and environmental conditions:
Young adult animals (approx. 10 weeks old) were selected. Body weight variation was within +/- 20% of the sex mean.
Identification: Tail mark with marker pen.
A health inspection was performed prior to treatment, to ensure that the animals are in a good state of health. Special attention was paid to the ears, which were intact and free from any abnormality.

Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +- 3.0°C (actual range: 18.6 - 23.1°C), a relative humidity of 30-70% (actual range: 31 - 84%) and 12 hours artificial fluorescent light and 12 hours darkness per day. Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.
Accommodation
Individual housing in labeled Macrolon cages (MI type, height 12.5 cm) containing sterilized sawdust as bedding material (Woody-Clean type 3/4; Tecnilab-BMl BV, Someren , The Netherlands).
Acclimatization period
The acclimatization period was at least 5 days before the start of treatment under laboratory conditions. Accommodation was as described above except that the animals were group housed in Macrolon cages (Mill type, height 18 cm). Paper (Enviro-dri, Tecnilab-BMI BV, Someren, The Netherlands) was supplied as cage-enrichment.
Diet
Free access to standard pelleted laboratory animal diet (code VRF1, Altromin, Lage, Germany).
Water
Free access to tap water.
Results of analysis for each batch of diet (nutrients) and results of quarterly analysis of diet (contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All Certificates and results of analysis are retained in the NOTOX archives.
Vehicle:
dimethylformamide
Concentration:
The dorsal surface of both ears was epidermally treated (25 pul/ear) with the test substance concentration, at approximately the same time per day.
Four concentrations were tested: vehicle control, 5%, 25% and 50% test substance.
No. of animals per dose:
5
Details on study design:
Three groups of five animals were treated with one test substance concentration per group. One group of five animals was treated with vehicle.
Parameter:
SI
Value:
<= 1
Test group / Remarks:
Vehicle control
Parameter:
SI
Value:
1.1
Variability:
+- 0.4
Test group / Remarks:
5% test substance
Parameter:
SI
Value:
1.4
Variability:
+- 0.3
Test group / Remarks:
25% test substance
Parameter:
SI
Value:
1.8
Variability:
+- 0.3
Test group / Remarks:
50% test substance
Cellular proliferation data / Observations:
The majority of nodes were considered normal in size, except for one node of a control animal. This node was reduced in size. No macroscopic abnormalities of the surrounding area were noted.

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.

No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Interpretation of results:
GHS criteria not met
Conclusions:
The SI values calculated for the substance concentrations 5, 25 and 50% were 1.1, 14 and 1,8 respectively.
There was no indication that the test substance could elicit an SI > 3. lt was established that the EC3 value (if any) exceeds 50%.

Based on these results:
- according to the recommendations made in the test guidelines, V123109 would not be regarded as skin Sensitizer.
- according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (New York and Geneva, 2003), V123109 does not have to be classified for sensitization by skin contact.
- according to the EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 671548/EEC), V123109 does not have to be classified and has no obligatory labeling requirement for sensitization by skin contact.
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification