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EC number: 230-237-7 | CAS number: 6976-37-0
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Deviation in sample preparation without any presumed effect on the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Deviation in sample preparation without any presumed effect on the study
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol
- EC Number:
- 230-237-7
- EC Name:
- 2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol
- Cas Number:
- 6976-37-0
- Molecular formula:
- C8H19NO5
- IUPAC Name:
- 2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Product no. B4429, Lot no. SLBK5235V
- Expiration date of the lot/batch: 30 April 2018
- Purity test date: na
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: TOXI COOP ZRT. Cserkesz u. 90., 1103 Budapest, Hungary
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 18.2 - 21.0 g
- Fasting period before study: unknown
- Housing: group caging (4 mice/cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): not available
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: Pluronic
- Remarks:
- aequous 1% (w/v) Pluronic(R)PE9200
- Concentration:
- 5, 10 and 25% (max. concentration determined by solubility)
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The substance's solubility in seven recommended solvents was tested.
- Irritation: no irritation was observed for the three concentration 5, 10 and 25% in a preliminary test
- Systemic toxicity: no toxicity was observed for the three concentration 5, 10 and 25% in a preliminary test
- Ear thickness measurements: no changes in ear thickness were observed for the three concentration 5, 10 and 25% in a preliminary test
- Erythema scores: all 0 for all concentrations, mice and time points (days 1, 2, 3, 4, 5, 6)
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: animals were assigned randomly achieving body weight homogeneity between groups
- Criteria used to consider a positive response: stimulation index of one concentration > 3
TREATMENT PREPARATION AND ADMINISTRATION: 25µL of the three respective formulations (substance dissolved in Pluronic) were applied to the dorsal surface of each ear using a pipette - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- none
Results and discussion
- Positive control results:
- Stimulation index (SI) of 25% (w/v) hexyl cinnamic aldehyde: 6.7
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- 25%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Disintegration per minute (per mouse (average)):
vehicle control: 772.8
5.0%: 478.3
10%: 764.0
25%: 1290.3
DETAILS ON STIMULATION INDEX CALCULATION: ratio of DPM/mouse of test concentrations and vehicle control
EC3 CALCULATION: not applicable
CLINICAL OBSERVATIONS: no irritation or other effects observed
BODY WEIGHTS: no treatment related effects
Any other information on results incl. tables
In a GLP-Study according to OECD TG 429 (LLNA), the substance, which was tested up to 25% in aqueous 1% Pluronic
(limited due to solubility), did not induce any skin sensitisation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The substance potential to induce skin sensitisation was investigated in a GLP-study according to OECD TG 429 (Local Lymph Node Assay).
Based on solubility experiments with seven potential vehicles, the substance was solved in aqueous 1% Pluronic. In a preliminary test, concentrations of 5, 10 and 25% did not induce irritation, increase ear thickness or show any other toxicity effects.
In the main test with four female CBA/CA mice per concentration and control (randomly assigned), the concentrations of 2 5, 10 and 25%
resulted in stimulation indices of 0.6, 1.0 and 1.7, respectively. As all indices were below 3 and no dose-response was apparent, the substance is considered as non skin sensitising.
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