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EC number: 946-101-1 | CAS number: -
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 20, 2017 to March 22, 2017
- 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Phosphoric acid, mono- and di- (C16-20 - (even numbered, branched and linear)-alkyl esters
- IUPAC Name:
- Phosphoric acid, mono- and di- (C16-20 - (even numbered, branched and linear)-alkyl esters
- Reference substance name:
- Isooctadecan-1-ol
- EC Number:
- 248-470-8
- EC Name:
- Isooctadecan-1-ol
- Cas Number:
- 27458-93-1
- Molecular formula:
- C18H38O
- IUPAC Name:
- Isooctadecan-1-ol
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Phosphoric acid, mono- and bis (C16-20 branched and linear alkyl) esters
- Batch: CH 200529/001
- Composition: UVCB
- Appearance: Lightly yellow liquid
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: Janvier, Le Genest-Saint-Isle, France.
Number of animals: 20 females (nulliparous and non-pregnant), five females per group (main study only).
Age and body weight: young adult animals (approx. 8-9 weeks old) were selected.
Body weight variation was within +/- 20% of the sex mean.
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle.
Diet: free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Water: free access to tap water.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 5, 10 and 25% w/w
- No. of animals per dose:
- 5
- Details on study design:
- The test substance concentrations selected for the main study were based on the results of a pre-screen test. In the main study, three experimental groups of five female CBA/J mice were treated with test substances concentrations of 5, 10 or 25% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with the vehicle alone (Acetone/Olive oil (4:1 v/v)). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of disintegrations per minute (DPM) and a stimulation index (SI) was subsequently calculated for each group.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- SI and EC3 values
Results and discussion
- Positive control results:
- The SI values calculated for the positive control concentrations 5, 10 and 25% were 1.4, 2.4 and 4.3, respectively. An EC3 value of 14.7% was calculated using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 4.8 and 19.5%. The results of the 6 monthly HCA reliability checks of the recent years were 13.4, 14.1, 17.3, 9.8, 17.8% and 18.0%.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- >= 1.4 - <= 6.1
- Test group / Remarks:
- test substance concentrations of 5, 10 and 25% w/w
- Key result
- Parameter:
- EC3
- Value:
- 9.7
- Test group / Remarks:
- test substance groups
- Cellular proliferation data / Observations:
- - No erythema was observed in any of the animals, scaliness was noted for all animals treated at 25% and some animals treated at 10% between Days 4 and 6.
- The majority of auricular lymph nodes were considered normal in size, except for one node in one animal treated at 25%, which was considered enlarged. No macroscopic abnormalities of the surrounding area were noted for any of the animals.
- Mean DPM/animal values for the experimental groups treated with test substance concentrations 5, 10 and 25% were 644, 1406 and 2811 DPM, respectively. The mean DPM/animal value for the vehicle control group was 460 DPM. The SI values calculated for the test substance concentrations 5, 10 and 25% were 1.4, 3.1 and 6.1, respectively. These results indicate that the test substance could elicit a SI ≥ 3. The data showed a dose-response and an EC3 value (the estimated test substance concentration that will give a SI =3) of 9.7% was calculated.
- No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Based on these results:
- according to the recommendations made in the test guidelines (including all amendments), the test substance would be regarded as skin sensitizer.
- according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments), the test substance should be classified as skin sensitizer (Category 1B).
- according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), the test substance should be classified as skin sensitizer (Category 1B) and labeled as H317: May cause an allergic skin reaction.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria met
- Remarks:
- Category 1B
- Conclusions:
- Under the study conditions, the test substance was considered to a skin sensitizer (LLNA).
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance according to OECD Guideline 429, EU Method B42 and US EPA OPPTS 870.2600 (LLNA), in compliance with GLP. The test substance concentrations selected for the main study were based on the results of a pre-screen test. In the main study, three experimental groups of five female CBA/J mice were treated with test substances concentrations of 5, 10 or 25% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with the vehicle alone (Acetone/Olive oil (4:1 v/v)). A positive control group (alpha-hexylcinnamaldehyde) was also included in the experiment. Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of disintegrations per minute (DPM) and a stimulation index (SI) was subsequently calculated for each group. Mortality/viability, body weights, clinical signs, and irritation (and other local effects) were recorded as well. No erythema was observed in any of the animals, scaliness was noted for all animals treated at 25% and some animals treated at 10% between Days 4 and 6. The majority of auricular lymph nodes were considered normal in size, except for one node in one animal treated at 25%, which was considered enlarged. No macroscopic abnormalities of the surrounding area were noted for any of the animals. Mean DPM/animal values for the experimental groups treated with test substance concentrations 5, 10 and 25% were 644, 1406 and 2811 DPM, respectively. The mean DPM/animal value for the vehicle control group was 460 DPM. The SI values calculated for the test substance concentrations 5, 10 and 25% were 1.4, 3.1 and 6.1, respectively. These results indicate that the test substance could elicit a SI ≥ 3. The data showed a dose-response and an EC3 value (the estimated test substance concentration that will give a SI =3) of 9.7% was calculated. No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. Under the study conditions and based on the EC3 value, the test substance was considered to be a moderate skin sensitizer (van Sas, 2017).
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