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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:
2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2002
Deviations:
no
Remarks:
No deviations occurred that impacted the integrity of the study.
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
Novec 7300
IUPAC Name:
Novec 7300
Details on test material:
- Name of test material (as cited in study report): Novec 7300
- Physical state: Colorless, clear liquid
- Analytical purity: 99.85%
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Batch 41-2601-2240-7
- Expiration date of the lot/batch: 23 March, 2006
- Purity test date: 10 June, 2005

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was prepared in acetone/olive oil (4:1 v/v)

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Females (if applicable) nulliparous and non-pregnant:Yes
- Microbiological status of animals, when known: A health inspection was performed prior to treatment to ensure that the animals were in good health.
- Age at study initiation: 11 weeks old
- Weight at study initiation: Within 20% of the sex mean.
- Housing: Individually in Makrolon cages.
- Diet (e.g. ad libitum): Pelleted standard laboratory diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: None

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8-22.7 C
- Humidity (%): 23-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 13 April, 2005 To: 03 May, 2005

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
ca. 0.4
Test group / Remarks:
25% test article
Key result
Parameter:
SI
Value:
ca. 0.5
Test group / Remarks:
50% test article
Key result
Parameter:
SI
Value:
ca. 0.4
Test group / Remarks:
100% test article

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study, the test article is not considered a sensitizer.
Executive summary:

The skin sensitization potential of the test article was evaluated in mice. The study was conducted in compliance with OECD GLP (1997) regulations. The test method was based on OECD No. 429 (2002); EC Directive 67/548/EEC, An. V, B.42 (2004); OPPTS 870.2600 (2003) Test substance concentrations for the main study were based on the results of a preliminary study. The test article was combined with a vehicle (Acetone/Olive oil (4:1v/v)) for dosing. In the main study, 3 groups of 5 experimental animals were epidermally exposed to 25%, 50%, or 100% concentrations of the test substance (liquid) in vehicle on 3 consecutive days. 5 vehicle control animals were similarly treated with vehicle alone. 3 days after the last exposure, all animals were injected with 3H-methyl thymidine and after 5 hours the draining auricular lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed and expressed as DPM and a stimulation index was calculated for each group. The majority of nodes were considered normal in size, except for one node of one animal treated at 50% that was reduced in size. No macroscopic abnormalities of the surrounding area were noted. Mean DPM values for the 25%, 50% and 100% were 172, 220, and 179 respectively. The mean DPM/animal value for the vehicle control group was 447. 2 animals treated at 50% were found dead on day 6 after injection of 3H-methyl thymidine. Macroscopic examination did not reveal any abnormalities. No symptoms of systemic toxicity were observed in the surviving animals of the main study. The SI values for the 25, 50 and 100% concentrations were 0.4, 0.5, and 0.4 respectively. There was no indication that the test substance could elicit an SI >3 when tested up to 100%. Based on the results of the study, the test article is not considered a sensitizer.

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