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EC number: 220-499-0 | CAS number: 2785-87-7
- 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
Acute toxicity: oral: LD50 = 2600 mg/kg bw (similar to OECD 401 in rats, K, rel.2);
Acute toxicity: dermal: LD50 > 2000 mg/kg bw (OECD 402, K, rel. 1);
Acute toxicity: inhalation: waiver.
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:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Pre-guideline and pre-GLP study. Only basic data given but the study is comparable to OECD TG 401.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (no details on test substance, test animals, environmental conditions of animal room and body weight. )
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- no data
- Doses:
- 1220, 1730, 2470 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for toxicity and clinical signs daily for 14 days.
- Necropsy of survivors performed: Yes - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 600 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 900 - <= 3 600
- Mortality:
- Mortality was observed in 1/10 (Day 1), 4/10 (3 animals died on Day 1; one animal died on Day 2) and 10/10 animals (Day 1) at 1730, 2470 and 5000 mg/kg bw, respectively. No mortality was observed at 1220 mg/kg bw.
- Clinical signs:
- other: Lethargy was observed in all dose groups. Also, chromodacryorrhea, ptosis and ataxia were observed at 1220, 1730 and 2470 mg/kg bw, respectively.
- Gross pathology:
- - No macroscopic abnormalities were observed in 8/10, 8/10, 6/10 and 0/10 animals at 1220, 1730, 2470 and 5000 mg/kg bw, respectively.
- Necropsy of remaining animals revealed red/yellow/bloated intestines; red/bloated stomach; dark/mottled liver; kidneys - dark at 1730, 2470 and 5000 mg/kg bw; lungs dark at 2470 and 5000 mg/kg bw; yellow anogenital exudate at 2470 mg/kg bw and red nose/mouth exudate at 2470 and 5000 mg/kg bw. - Other findings:
- None
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions, test material is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- classified as category 5 according to the GHS since rat Oral LD50 is lower than 5000 mg/kg bw (2600 mg/kg bw) - Executive summary:
In an acute oral toxicity study, performed similarly to OECD Guideline No. 401, groups of rats (10 animals/dose) were administered a single oral dose of test material at 1220, 1730, 2470 and 5000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
All ten animals died at 5000 mg/kg bw. 1/10 and 4/10 animals died at 1730 and 2470 mg/kg bw. No mortality was observed at 1220 mg/kg bw. Lethargy was observed in all dose groups. Also chromodacryorrhea, ptosis and ataxia were observed at 1220, 1730 and 2470 mg/kg bw, respectively. No macroscopic abnormalities were observed in 8/10, 8/10, 6/10 and 0/10 animals at 1220, 1730, 2470 and 5000 mg/kg bw, respectively. Necropsy of remaining animals revealed red/yellow/bloated intestines; red/bloated stomach; dark/mottled liver; kidneys dark at 1730, 2470 and 5000 mg/kg bw; lungs dark at 2470 and 5000 mg/kg bw; yellow anogenital exudate at 2470 mg/kg bw and red nose/mouth exudate at 2470 and 5000 mg/kg bw.
Rat Oral LD50 = 2600 mg/kg bw (95% Cl: 1900-3600 mg/kg bw).
Under the test conditions, test material is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- classified as category 5 according to the GHS since rat Oral LD50 is lower than 5000 mg/kg bw (2600 mg/kg bw)
This study is considered as acceptable and satisfies the requirement for acute oral toxicity
Reference
Table 7.2.1.1 – Distribution of mortality
|
Observation day |
|||||||||||||
Dose (mg/kg bw) |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
1220 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1730 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2470 |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5000 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 600 mg/kg bw
- Quality of whole database:
- The key study performed on the registered substance in rats was pre-GLP, but was similar to OECD Test guideline No 401. This study was considered sufficiently robust to cover this endpoint.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- In accordance with Column 2 of REACH Annex VIII, in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 (acute toxicity by inhalation) and 8.5.3 (acute toxicity by the dermal route) shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. In the present case, inhalation exposure will be lower than dermal exposure because the registered substance has a low vapour pressure (3 Pa at 25°C) and a low freezing point (-6°C), so the potential for the generation of inhalable forms is low. Dermal exposure is the most likely route of exposure based on physico-chemical properties (Log Kow = 2.8 at 20°C, WS = 1.1 g/L at 20°C).
Reference
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:
- From June 10 to July 08, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR strain (VAF plus)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent
- Weight at study initiation: 200-300 g
- Housing: Animals were individually housed in grid bottomed cages suspended over cardboard lined excreta trays.
- Diet: Pelleted rodent diet (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, produced by Special Diets Services, Witham, Essex), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-24 °C
- Humidity: 47-66 %
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: June 10, 1992 To: July 08, 1992 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back area
- Type of wrap if used: A pad of surgical gauze 4 plies thick was placed on treated area and semi-occluded with an 'Elastoplast' elastic adhesive bandage (0.5 cm wide).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Dressings were removed and treated skin was washed by gentle swabbing with cotton wool soaked in warm water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed for mortality and clinical signs shortly after dosing and approximately 30 minutes, 1, 2 and 4 h after dosing and daily thereafter for 14 days. Individual body weights were recorded on Days 1, 8 and 15.
- Necropsy of survivors performed: Yes; after the 14 days observation period, all animals were killed by carbon dioxide asphyxiation and subjected to gross necropsy. - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - No mortality was observed.
- Clinical signs:
- other: - 2/5 females showed urogenital staining 4 h after dosing. No other clinical signs were observed.
- Gross pathology:
- - One male showed minimal dilation of right kidney pelvis and one female showed moderate dilation of both kidney pelvises. No significant abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the available information, the substance is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met). - Executive summary:
In an acute dermal toxicity study (limit test) performed similarly to OECD Guideline No. 402 and in compliance with GLP, a group of Crl:CD(SD)BR strain (VAF plus) rats (5/sex) was given a single dermal application of the undiluted test material at 2000 mg/kg bw to the clipped back area. Test sites were covered with a semi-occlusive dressing for 24 h. Animals were observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study all animals were sacrificed for macroscopic examination. Range finding study was conducted at the dose levels of 400, 1000 and 2000 mg/kg bw (1 rat/sex/dose) to determine the dose levels for the main study.
In the range-finding study, no mortality or clinical signs were observed at any dose level. In the main study, no mortality or clinical signs were observed except 2/5 females showed urogenital staining 4 h after dosing. No significant abnormalities were noted at necropsy.
Dermal LD50 Combined > 2000 mg/kg bw
Based on the available information, the substance is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).
This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.
Reference
Range-finding study:
- No mortality or clinical signs were observed at any dose level over 7 days study period.
Table 7.2.3/1: Individual bodyweights and bodyweight changes
Dose level (mg/kg bw) |
Animal number and sex |
Body weight (g) at Day |
Change in body weight Day 1-15 |
||
1 |
8 |
15 |
|||
2000 |
61 Male |
253 |
297 |
351 |
98 |
62 Male |
255 |
311 |
390 |
135 |
|
63 Male |
259 |
299 |
362 |
103 |
|
64 Male |
260 |
308 |
366 |
106 |
|
65 Male |
246 |
291 |
353 |
107 |
|
Mean ± S.D |
255 ± 5.6 |
301 ± 8.2 |
364 ± 15.6 |
110 ± 14.5 |
|
66 Female |
221 |
230 |
247 |
26 |
|
67 Female |
232 |
234 |
255 |
23 |
|
68 Female |
234 |
247 |
269 |
35 |
|
69 Female |
220 |
227 |
249 |
29 |
|
70 Female |
212 |
226 |
238 |
26 |
|
Mean ± S.D |
224 ± 9.1 |
233 ± 8.5 |
252 ± 11.5 |
28 ± 4.5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The key study performed on the registered substance in rats was GLP and was compliant with OECD Test guideline No 402 (Klimisch 1). This study was considered sufficiently robust to cover this endpoint.
Additional information
Acute toxicity: oral
A key study was identified (MB Research laboratories, 1978, rel.2). This study was non-GLP, but was similar to OECD Test guideline No 401. Groups of rats (10/dose) were administered a single oral dose of test material at 1220, 1730, 2470 and 5000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
1/10, 4/10 and 10/10 animals died at 1730, 2470 and 5000 mg/kg bw, respectively. No mortality was observed at 1220 mg/kg bw. Lethargy was observed in all dose groups. Also chromodacryorrhea, ptosis and ataxia were observed at 1220, 1730 and 2470 mg/kg bw, respectively. Necropsy revealed red/yellow/bloated intestines; red/bloated stomach; dark/mottled liver; kidneys dark at 1730, 2470 and 5000 mg/kg bw; lungs dark at 2470 and 5000 mg/kg bw; yellow anogenital exudate at 2470 mg/kg bw and red nose/mouth exudate at 2470 and 5000 mg/kg bw.
Rat Oral LD50 = 2600 mg/kg bw (95% Cl: 1900-3600 mg/kg bw).
Acute
toxicity: inhalation
In accordance with Column 2 of REACH Annex VIII, in
addition to the oral route (8.5.1), for substances other than gases, the
information mentioned under 8.5.2 (acute toxicity by inhalation) and
8.5.3 (acute toxicity by the dermal route) shall be provided for at
least one other route. The choice for the second route will depend on
the nature of the substance and the likely route of human exposure. In
the present case, inhalation exposure will be lower than dermal exposure
because the registered substance has a low vapour pressure (3 Pa at
25°C) and a low freezing point (-6°C), so the potential for the
generation of inhalable forms is low. Dermal exposure is the most likely
route of exposure based on physico-chemical properties (Log Kow = 2.8 at
20°C, WS = 1.1 g/L at 20°C).
Acute toxicity: dermal
A key study was identified (Toxicol, 1992, rel.1). In an acute dermal toxicity study (limit test) performed similarly to OECD Guideline No. 402 and in compliance with GLP, a group of Crl:CD(SD)BR strain (VAF plus) rats (5/sex) was given a single dermal application of the undiluted test material at 2000 mg/kg bw to the clipped back area. Test sites were covered with a semi-occlusive dressing for 24 h. Animals were observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study all animals were sacrificed for macroscopic examination. Range finding study was conducted at the dose levels of 400, 1000 and 2000 mg/kg bw (1 rat/sex/dose) to determine the dose levels for the main study.
In the range-finding study, no mortality or clinical signs were observed at any dose level. In the main study, no mortality or clinical signs were observed except 2/5 females showed urogenital staining 4 h after dosing. No significant abnormalities were noted at necropsy.
Dermal LD50 Combined > 2000 mg/kg bw
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity via Oral route:
Based on the available data, the substance is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- classified as category 5 according to the GHS since rat Oral LD50 is lower than 5000 mg/kg bw (2600 mg/kg bw)
Acute toxicity via Dermal route:
Based on the available data, the substance is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).
Acute toxicity (Inhalation):
No data was available.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.
The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.
Specific target organ toxicity: single exposure (Dermal):
The classification criteria according to the Annex VI of the Regulation (EC) No 1272/2008 as specific target organ toxicant (STOT) – single exposure, dermal are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (dermal) for a Category 1 classification (C≤ 1000 mg/kg bw) and at the guidance value (dermal) for a Category 2 classification (2000 mg/kg bw≥C > 1000 mg/kg bw). No classification is required.
The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute dermal toxicity study.
Specific target organ toxicity: single exposure (Inhalation):
Based on the classification for skin and eye irritation, the substance should be classified by default and as a worst-case as STOT-SE Category 3 (H335: May cause respiratory irritation) according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
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