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Registration Dossier
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EC number: 308-114-5 | CAS number: 97862-65-2
Endpoint summary
Administrative data
Description of key information
The substance was not skin sensitizing in the LLNA (OECD 429, GLP).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V.,lnc ., Postbus 6174, 5960 AD Horst, The Netherlands
- Females (if applicable) nulliparous and non-pregnant:yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: Ca. 15 - 25 g
- Housing: single cages
- Diet (e.g. ad libitum): ad libtum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 15 Nov 2016 To: 5 Dec 2016 (main study) (Pre-tests for dose-selection and vehicle selection were performed before the main study) - Vehicle:
- dimethylformamide
- Concentration:
- 1, 2.5 and 5%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The substance is generally of poor solubility. In DMF, a homogeneous suspension could be achieved.
- Irritation: Concentrations exceeding 5% im DMF were irritating to the skin of mice ears.
- Systemic toxicity:
- Ear thickness measurements:
- Erythema scores:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:3H-Thymidine incorporation
- Criteria used to consider a positive response: SI > 3
TREATMENT PREPARATION AND ADMINISTRATION: Test substance was weighed and mixed with the vehicle shortly before treatment. Homogeneity was achieved by stirring with a magnetic stirrer. - Parameter:
- SI
- Value:
- 1.52
- Test group / Remarks:
- 1%
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 2.5%
- Parameter:
- SI
- Value:
- 1.41
- Test group / Remarks:
- 5%
- Parameter:
- EC3
- Remarks on result:
- not determinable
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
See table 2
DETAILS ON STIMULATION INDEX CALCULATION
EC3 CALCULATION
An EC3 could not be calculated because there was no dose-dependent increase and no values above 3.
CLINICAL OBSERVATIONS:
BODY WEIGHTS
See table 4 - Interpretation of results:
- GHS criteria not met
Reference
Table 1: 3H-Thymidine incorporation
| DPM / lymph node pair | S.D. | Stimulation Index | |
| vehicle DMF | 982.9 | 232.8 | 1.00 |
| 1% in DMF | 1493.9 | 331.5 | 1.52 |
| 2.5% in DMF | 1184.0 | 384.2 | 1.20 |
| 5% in DMF | 1389.7 | 167.8 | 1.41 |
Table 2: Cell counts
| Mean [Counts / lymph node pair] |
S.D. | Stimulation Index | |
| vehicle DMF | 11'946'000 | 1'401'690 | 1.00 |
| 1% in DMF | 14'852'400 | 3'134'248 | 1.24 |
| 2.5% in DMF | 13'856'400 | 2'179'411 | 1.16 |
| 5% in DMF | 14'186'400 | 2'122'103 | 1.19 |
Table 3: Lymph node weights
| Mean [mg] | S.D. | Stimulation Index | |
| vehicle DMF | 5.2 | 0.5 | 1.00 |
| 1% in DMF | 5.7 | 0.9 | 1.08 |
| 2.5% in DMF | 5.5 | 0.7 | 1.06 |
| 5% in DMF | 5.6 | 0.9 | 1.07 |
Table 4: Body weights
| Mean Weight d0 | S.D. | Mean Weight d5 | S.D. | |
| vehicle DMF | 19.8 | 1.1 | 20.7 | 1.2 |
| 1% in DMF | 19.3 | 0.7 | 20.2 | 0.8 |
| 2.5% in DMF | 19.7 | 0.5 | 20.7 | 0.5 |
| 5% in DMF | 18.8 | 1.1 | 19.8 | 1.2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The stimulation indices in the LLNA (OECD 429) did not show a dose dependent increase. No EC3 could be established. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008,as amended for the seventh time in Regulation (EC) No 2015/1221.
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