Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 942-425-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral: LD50 > 5000 mg/kg bw (similar to OECD 401, K, rel. 2).
Acute toxicity: dermal: LD50 > 2000 mg/kg bw (similar to OECD 402, K, rel. 2).
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:
- From June 14 to June 28, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study comparable to OECD test guideline No. 401 but GLP status not reported.
- Reason / purpose:
- reference to same study
- Reason / purpose:
- reference to other study
- Qualifier:
- equivalent or similar to
- Guideline:
- other: Section 1500.3 - Federal Hazardous Substances Act Regulations - 16 CFR
- Deviations:
- no
- Qualifier:
- equivalent or similar to
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA.
- Age at study initiation: no data
- Weight at study initiation: 200-300 g
- Fasting period before study: overnight deprivation of food
- Housing: 5 rats/cage by sex, in stainless steel cages with elevated wire mesh flooring
- Diet (e.g. ad libitum): Wayne Lab-Blox ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: appropriate time
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- None
- Doses:
- 5000 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: frequently on the day of dosage, and twice per day thereafter.
- Frequency of weighing: on the day of dosage (individually), and on Day 7 and 14 after dosing (grouped)
- Necropsy of survivors performed: yes, gross examinations - Statistics:
- none
- Preliminary study:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- All animals appeared normal throughout the 14 day observation period
- Body weight:
- All animals gained weight
- Gross pathology:
- No gross abnormalities
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oral LD50Combined > 5000 mg/kg bw
- Executive summary:
In a limit acute oral toxicity study performed similarly to the OECD test guideline No. 401, a group of fasted, Sprague-Dawley rats (5/sex) was administered a single oral dose of undiluted test material at 5000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.
No mortality and no clinical signs were observed throughout the study. There was no adverse effect on bodyweight gain. No gross abnormalities were observed at necropsy.
Oral LD50Combined > 5000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The key study is of good quality (Klimisch score = 2) although GLP status is not reported.
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:
- From June 15 to June 29, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study comparable to OECD test guideline No. 402 with deviations not affecting the integrity of the result. Indeed, only 6 animals were tested instead of the 10 required by the OECD Test Guideline No. 402 for a limit test. However having 4 more animals would not impact the LD50 value since no mortality occurred within this study. Moreover half of the animals had abraded skin which improved skin permeability, and therefore absorption. GLP status not reported.
- Reason / purpose:
- reference to same study
- Reason / purpose:
- reference to other study
- Qualifier:
- equivalent or similar to
- Guideline:
- other: Section 1500.4 - Federal Hazardous Substance Act Regulation - 16 CFR
- Deviations:
- no
- Qualifier:
- equivalent or similar to
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Limit test using 6 animals instead of 10, half of them having abraded skin
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA.
- Age at study initiation: no data
- Weight at study initiation: 2.3-3.0 kg bw.
- Fasting period before study: no.
- Housing: individually, in stainless steel cages with elevated wire mesh flooring.
- Diet (e.g. ad libitum): Wayne 15% Rabbit ration ad libitum.
- Water (e.g. ad libitum): tap water ad libitum.
- Acclimation period: appropriate time.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 - 23
- Humidity (%): 40-45
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: backs (clipped skin, 3 with abraded skin).
- % coverage: approximately 10%.
- Type of wrap if used: large gauze patches, impervious material wrapped snugly around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no (wiping only)
- Time after start of exposure: 24 hours.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bw. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (systemic and topical): frequently during the first day, and twice per day thereafter (morning and afternoon).
- Frequency of weighting: on the day of dosage, weekly thereafter, and prior to sacrifice.
- Necropsy of survivors performed: yes (gross necropsy) - Statistics:
- None
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- None.
- Body weight:
- A loss of body weight was noted for 1/3 female at 7 days.
- Gross pathology:
- No gross abnormalities were noted.
- Other findings:
- Mild erythema and severe oedema were observed after unwrapping at 24 hours. Eschar was noted for all animals by day 4 which was still evident at 14 days.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dermal LD50Combined > 2000 mg/kg bw
- Executive summary:
In a limit acute dermal toxicity study performed similarly to the OECD test guideline No. 402, New Zealand White rabbits (3/sex) were occlusively exposed to undiluted test material for 24 hours at dose of 2000 mg/kg bw. The animals were observed for mortality, clinical signs including dermal reactions and body weight for 14 days and then necropsied for macroscopic observations.
No mortality and no clinical signs were observed during the study. A loss of body weight was noted for 1/3 female at 7 days.
Mild erythema and severe oedema were observed after unwrapping at 24 hours. Eschar was noted for all animals by day 4 which was still evident at 14 days.
Dermal LD50Combined > 2000 mg/kg bw.
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The key study is of good quality (Klimisch score = 2) although GLP status is not reported. Deviations do not affect the integrity of the result.
Additional information
Acute toxicity via oral route:
A key study was identified (Biosearch Inc., 1984). In this limit acute oral toxicity study performed similarly to the OECD test guideline No. 401, rats (5/sex) were administered a single oral dose of undiluted test material at 5000 mg/kg bw by gavage. No mortality and no clinical signs were observed throughout the study. There was no adverse effect on bodyweight gain. No gross abnormalities were observed at necropsy.
Oral LD50Combined > 5000 mg/kg bw.
Acute toxicity via dermal route:
A key study was identified (Biosearch Inc., 1984). In this limit acute dermal toxicity study performed similarly to the OECD test guideline No. 402, rabbits (3/sex, half clipped and half abraded)were occlusively exposed to undiluted test material for 24 hours at dose of 2000 mg/kg bw. No mortality and no clinical signs were observed during the study. A loss of body weight was noted for 1/3 female at 7 days. Mild erythema and severe oedema were observed after unwrapping at 24 hours. Eschar was noted for all animals by day 4 which was still evident at 14 days.
Dermal LD50Combined > 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Only one study available
Justification for selection of acute toxicity – inhalation endpoint
Not required for substances at the REACH Annex VII tonnage level.
Justification for selection of acute toxicity – dermal endpoint
Only one study available
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP6.
Self-classification:
Acute toxicity (Oral):
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 5000 mg/kg bw.
Acute toxicity (Dermal):
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 dermal LD50 is higher than 2000 mg/kg bw.
Acute toxicity (Inhalation):
No information 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 required.
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 required.
Specific target organ toxicity: single exposure (Inhalation):
No information was available.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Route: .live2