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EC number: 221-361-2 | CAS number: 3077-27-8
- 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
Endpoint summary
Administrative data
Description of key information
Oral (OECD 423), rat, LD50 > 2000 mg/kg bw
Dermal (OECD 402), rat, LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 - 30 Aug 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Slovak National Accreditation Service, Karloveska 63, 840 00 Bratislava 4, Slovak Republic
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 180 - 205 g
- Fasting period before study: over night and 3 - 4 h post-administration
- Housing: 3 animals per cage
- Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
- Diet: ssniff (Spezialdiäten GmbH, Germany), provided at recommended doses each day approximately at the same time
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.18 ± 0.45
- Humidity (%): 55.40 ± 3
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: 15 - 30 August 2017 - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: Olive oil is a standard vehicle according to OECD 423
- Lot/batch no.: L63417
- Expiry date: 06/2018
- Manufacturer: Oleificio Luca, Italy
- Storage temperature (°C): 20 ± 5
CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. Hence, the limit dose of 2000 mg/kg body weight was used as a starting dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: immediately after dosing, 0.5, 1, 2 and 4 h after administration
- Frequency of weighing: immediately prior to dosing and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 is cut-off according to OECD 423
- Mortality:
- All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.
- Clinical signs:
- During the observation period, no animals displayed signs of intoxication, change of health, or any other adverse reaction.
- Body weight:
- The body weight of all animals increased during the study. No body weight losses were observed between the first and second week after administration.
- Gross pathology:
- During necropsy, no macroscopic findings were observed.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The LD50 of the test item has been determined to be greater than 2000 mg/kg body weight after single oral administration to female Wistar rats.
Based on 'Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight' of OECD 423 it can also be concluded that the LD50 cut-off value is equal to or greater than 5000 mg/kg body weight after single oral administration to Wistar rats.
Reference
Table 1: Body Weights and Body Weight Differences
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 - Week 1 |
|||
♀ |
2000 mg/kg |
1 |
205 |
210 |
215 |
5 |
10 |
5 |
2 |
185 |
190 |
200 |
5 |
15 |
10 |
||
3 |
190 |
190 |
200 |
0 |
10 |
10 |
||
4 |
190 |
200 |
205 |
10 |
15 |
5 |
||
5 |
190 |
200 |
210 |
10 |
20 |
10 |
||
6 |
180 |
210 |
220 |
30 |
40 |
10 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No. 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 - 31 Aug 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- Version / remarks:
- Proposal for a New Draft Guideline, May 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Slovak National Accreditation Service, Karloveska 63, 840 00 Bratislava 4, Slovak Republic
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 195 - 200 g (f), 220 - 230 g (m)
- Housing: 3 animals per cage
- Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
- Diet: ssniff (Spezialdiäten GmbH, Germany), provided at recommended doses each day approximately at the same time
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.18 ± 0.45
- Humidity (%): 55.40 ± 3
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: 15 - 31 August 2017 - Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped and shaved dorsal area of trunk
- % coverage: approx. 10% of total body surface area
- Type of wrap if used: semi-occlusive dressing with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: residual test item was removed with lukewarm water
- Time after start of exposure: 24 h
VEHICLE
- Justification for choice of vehicle: Olive oil is a standard vehicle according to test guideline
- Lot/batch no.: L63417
- Expiry date: 06/2018
- Manufacturer: Oleificio Luca, Italy
- Storage temperature (°C): 20 ± 5
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. Hence, a limit dose of 2000 mg/kg body weight was used as a starting dose. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: immediately after dosing, 0.5, 1, 2 and 4 h after administration, daily for the next 14 days
- Frequency of weighing: immediately prior to dosing and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All 5/5 females and 5/5 males at the limit dose of 2000 mg/kg body weight survived.
- Clinical signs:
- Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were observed.
- Body weight:
- The body weight of all females increased during the study, stagnation of body weight in two females between the first and second week was noticed.
- Gross pathology:
- All animals (5 females and 5 males) were necropsied. During necropsy, no macroscopic changes were noticed.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The LD50 of the test item has been determined to be greater than 2000 mg/kg body weight after single dermal administration to male and female Wistar rats.
Reference
Table 1: Body Weights and Body Weight Differences
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 - Week 1 |
|||
♀ |
2000 mg/kg |
1 |
195 |
205 |
210 |
10 |
15 |
5 |
2 |
200 |
200 |
225 |
0 |
25 |
25 |
||
3 |
200 |
200 |
215 |
0 |
15 |
15 |
||
4 |
200 |
220 |
220 |
20 |
20 |
0 |
||
5 |
195 |
210 |
210 |
15 |
15 |
0 |
||
♂ |
2000 mg/kg |
6 |
230 |
250 |
275 |
20 |
45 |
25 |
7 |
230 |
250 |
270 |
20 |
40 |
20 |
||
8 |
230 |
235 |
250 |
5 |
20 |
15 |
||
9 |
230 |
245 |
260 |
15 |
30 |
15 |
||
10 |
220 |
245 |
260 |
25 |
40 |
15 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No. 1907/2006.
Additional information
Acute toxicity: oral
The acute toxicity via the oral route was investigated in rats in a study performed according to OECD 423 and in compliance with GLP (hameln, 2017a). A group of 6 female rats was treated with the limit dose of 2000 mg/kg bw of the test substance via oral gavage. The observation period following administration was 14 days. During the study period, no animal died. No clinical signs of toxicity were observed in the surviving animals. All surviving animals showed normal body weight gain. Necropsy did not reveal any macroscopic findings. Thus, the oral LD50 value for female rats was considered to be greater than 2000 mg/kg bw.
Acute toxicity: inhalation
No data on acute inhalation toxicity is required as data on two other routes of exposure, i.e. oral and dermal, are provided.
Acute toxicity: dermal
The acute dermal toxicity was evaluated in rats in accordance with OECD 402 under GLP conditions (hameln, 2017b). Groups of 10 rats (5 males and 5 females) were treated with the test substance dissolved in olive oil at the limit dose of 2000 mg/kg bw under semi-occlusive conditions for 24 h. The animals were observed for a period of 14 days following administration. During the study period, no mortality and no clinical signs of toxicity occurred in any animal. No substance-related findings during necropsy were observed in any animal. No effects on body weight gain were observed with the exception of two females that showed stagnation of body weight between the first and second week. Thus, the dermal LD50 for male and female rats was considered to be greater than the tested limit dose of 2000 mg/kg bw.
Conclusion
Taken together, the available data on oral and dermal acute toxicity do not indicate any relevant acute toxicity.
Justification for classification or non-classification
The available data on acute oral and acute dermal toxicity of the registered substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are, therefore, conclusive but not sufficient for classification. Due to the lacking of suitable data, no assessment with respect to acute inhalation toxicity is possible.
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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