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EC number: 203-602-3 | CAS number: 108-64-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-11-03 to 2017-02-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ethyl propionate
- EC Number:
- 203-291-4
- EC Name:
- Ethyl propionate
- Cas Number:
- 105-37-3
- Molecular formula:
- C5H10O2
- IUPAC Name:
- ethyl propionate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Males 8 weeks old; Females 9 weeks old
- Weight at study initiation: Males 267.5-283.4g; Females 217.6-231.5g
- Housing: one animal per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: for four days after three days of quarantine (including health examinations)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1-24.6°C (measured), permissible range 19.0-25.0°C
- Humidity (%): 47.7-61-7% (measured), permissible range 30.0-70.0%
- Air changes (per hr): 10-15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal surface
- % coverage:
- Type of wrap if used: lint, Soft Cloth Tape with Liner and surgical tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton moistened with tepid water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.25 mL/kg bw
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose;
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for mortality, clinical signs, general conditions at 30 minutes after dosing and at 1, 2, 4, 6 hours after dosing on day 0 and once daily thereafter for 14 days; body weight was recorded prior to dosing on day 0 and on day 1, 3, 7, and on day of necropsy, day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no histopathology, since no gross findings were observed at necropsy. - Statistics:
- Statistical analysis was performed using SAS progam V9.3.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals at 2000 mg/kg bw and in the control group survived the duration of the study. There were no effects on the mortality. (see table 1)
- Clinical signs:
- other: All animals at 2000 mg/kg bw and in the control group showed no abnormalities of clinical signs. (see table 2)
- Gross pathology:
- No grossly visible evidence of morphological abnormalities were observed in any animal at 2000 mg/kg bw or in the control group.
Any other information on results incl. tables
Table 1: Summary of Mortality
Sex |
dose (mg/kg) |
No. animals |
Days after dosing |
mortality |
||||||||||||||
|
|
|
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
male |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/5 |
|
2000 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Female |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/5 |
|
2000 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/5 |
Table 2: Individual Clinical Signs
Sex |
Dose (mg/kg) |
No. animals |
Clinical sign |
Hours (day 0) after dosing |
||||
|
|
|
|
0.5 |
1 |
2 |
4 |
6 |
Male |
0 |
5 |
NOA |
5 |
5 |
5 |
5 |
5 |
|
2000 |
5 |
NOA |
5 |
5 |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
Female |
0 |
5 |
NOA |
5 |
5 |
5 |
5 |
5 |
|
2000 |
5 |
NOA |
5 |
5 |
5 |
5 |
5 |
Sex |
Dose (mg/kg) |
No. animals |
Clinical sign |
Days after |
|||||||||||||
|
|
|
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Male |
0 |
5 |
NOA |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
2000 |
5 |
NOA |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Female |
0 |
5 |
NOA |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
2000 |
5 |
NOA |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
NOA: No observable abnormality
Table 3: Individual Body Weights
Sex |
Dose |
|
Days after dosing |
Gain |
|||
|
|
|
0 |
3 |
7 |
14 |
0-14 |
Male |
0 |
Mean |
274.9 |
288.3 |
315.7 |
358.1 |
83.2 |
|
|
S.D. |
3.2 |
1.9 |
6.9 |
12.8 |
12.4 |
|
|
N |
5 |
5 |
5 |
5 |
5 |
|
2000 |
Mean |
276.0 |
284.1 |
305.2 |
344.9 |
68.9 |
|
|
S.D. |
6.8 |
10.2 |
12.1 |
18.9 |
14.1 |
|
|
N |
5 |
5 |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
Female |
0 |
Mean |
225.5 |
228.0 |
237.2 |
248.4 |
22.9 |
|
|
S.D. |
4.9 |
3.2 |
7.5 |
14.0 |
10.0 |
|
|
N |
5 |
5 |
5 |
5 |
5 |
|
2000 |
Mean |
226.3 |
227.6 |
239.2 |
254.4 |
28.2 |
|
|
S.D. |
7.0 |
2.4 |
4.4 |
5.2 |
8.7 |
|
|
N |
5 |
5 |
5 |
5 |
5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of the acute dermal study in Sprague-dawley rats, the test substance has an LD50 value greater than 2000 mg/kg bw.
- Executive summary:
The purpose of this study was to assess the potential toxicity and the approximate LD50 value of the test substance following a single dermal application to Sprague-Dawley rats.
Test groups consisted of one dose group at a dose of 2,000 mg/kg and a control group, and each group consisted of 5 males and 5 females. All animals were monitored for clinical signs and body weight changes after dosing during the 14-day observation period. They were subjected to gross necropsy at the end of the observation period.
There were no deaths of animals in the 2,000 mg/kg groups. No test substance-related effects were observed in clinical signs, body weight data or necropsy findings in the 2,000 mg/kg groups.
Based on the result of this study, the LD50 value of the test substance was considered to be greater than 2,000 mg/kg in male and female rats under the conditions of this study. Therefore, it was not classified according to CLP.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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