Registration Dossier
Registration Dossier
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EC number: 209-952-3 | CAS number: 598-78-7
Endpoint summary
Administrative data
Description of key information
According to the CLP Regulation EC 1272/2008 Annex VI the substance is classified as Harmful, Xn R22 for acute oral toxicity or Acute Toxicity 4 (H302). A number of literature studies are reported from publicly available sources which support this classification.
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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data from Literature without sufficient experimental details.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No guideline or method is referenced.
- GLP compliance:
- not specified
- Test type:
- other: Acute method but no additional data presented
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No additional data presented
- Route of administration:
- other: No data presented
- Vehicle:
- not specified
- Details on oral exposure:
- No additional data presented
- Doses:
- No additional data presented
- No. of animals per sex per dose:
- No additional data presented
- Control animals:
- not specified
- Details on study design:
- No additional data presented
- Statistics:
- No additional data presented
- Preliminary study:
- No information on any preliminary study reported
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 800 mg/kg bw
- Remarks on result:
- other: Rat
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 400 mg/kg bw
- Remarks on result:
- other: This test was conducted on mice
- Mortality:
- No additional data presented
- Clinical signs:
- other: No additional data presented
- Gross pathology:
- No additional data presented
- Other findings:
- No additional data presented
- Interpretation of results:
- other: harmful
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 for 2-chloropropionic acid in male rats is reported as 800 mg/kg. In mice the LD50 is reported as 400 mg/kg/bw. This would result in a harmful classification under the EU system with the risk phrase R22, Harmful if swallowed and Acute Toxicity Category 4 under CLP.
- Executive summary:
The Toxnet website ( http://toxnet.nlm.nih.gov/ ) entry for 2 -chloropropionic acid contains a number of references to the American Conference of Governmental Industrial Hygienists(ACGIH). This is a professional association of industrial hygienists and practitioners of related professions.
With regard to acute toxicity, the LD50 in male rats is reported to be 800 mg/kg bw and in male mice is reported to be 400 mg/kg bw.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 400 mg/kg bw
- Quality of whole database:
- The data available is based in available literature sources and covers a wide range of values; the lowest value quoted has been taken as the ‘endpoint’ value. The data set is considered sufficient for the determination of classification.
Additional information
Annex VII of Regulation (EC) No 1907/2006 in section 8.5 states the study/ies do(es) not generally need to be conducted if : - the substance is classified as corrosive to the skin. This is reiterated in section R.7.4.2 of the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7a : Endpoint specific guidance.
Although this endpoint is not required for a substance classified as corrosive to skin, a number of acute oral toxicity studies are publicly available which are reported here.
Fourteen LD50 values are reported - these are summarised in the table below:-
| LD50 | Substance |
IUCLID 5 Endpoint | Species |
| 1671 mg/kg | Sodium 2 -chloropropionate | 001 | Mouse |
| 800 mg/kg and 400 mg/kg | 2 -Chloropropionic acid | 002 | Rat (800 mg/kg), Mouse (400 mg/kg) |
| 635 mg/kg | 2 -Chloropropionic acid | 003 | Rat |
| 500 mg/kg | 2 -Chloropropionic acid | 003 | Rat |
| 800 mg/kg | 2 -Chloropropionic acid | 003 | Rat |
| 890 mg/kg | Sodium 2 -chloropropionate | 003 | Rat |
| 2150 mg/kg | Sodium 2 -chloropropionate | 003 | Rat |
| 980 mg/kg | Sodium 2 -chloropropionate | 004 | Mouse |
| 1670 mg/kg | Sodium 2 -chloropropionate | 004 | Mouse |
| 400 mg/kg | Other test substance | 004 | Mouse |
| 980 mg/kg | 2-Chloropropionic acid | 004 | Mouse |
| 500 mg/kg | 2 -Chloropropionic acid | 005 | Rat |
| 535 mg/kg and 800 mg/kg | 2 -Chloropropionic acid | 006 | Not specified |
The IUCLID 4 dataset for 2-chloropropionic acid contains ten reported LD50 values. In four cases these relate to the sodium salt of 2-chloropropionic acid. GLP is quoted as "yes" in only one case. In the remainder of cases GLP is either "no" (three cases) or no information available. In all but one case the LD50 values reported are between 400 and 1670 mg/kg bw which would result in a harmful classification with the R22 risk phrase, Harmful if swallowed and under CLP [Regulation (EC) No 1272/2008 this
would result in an Acute Toxicity Category 4. One value is reported as 2150 mg/kg bw which would render the substace non classified for acute toxicity effects. However, this value is reported to be on the sodium salt. The substance is classified in Annex I of Directive 67/548/EEC as Harmful, Xn, with Risk Phrases R22 (Harmful if swallowed) and Acute Toxicity Category 4 under CLP with the Hazard Statement H302 (Harmful if swallowed).
One publication ( Journal of Pharmacology and Experimental Therapeutics, 1982, 222 (2), 501-508 - Comparison of the Metabolic and Toxic Effects of 2-Chloropropionate and Dichloroacetate) reports the LD50 (in mice) to be 15.4 mmol/kg bw (equivalent to 1671 mg/kg bw).
Given the endpoint values reported it is concluded that the LD50 for 2 -chloropropionic acid lies in the range 400 - 2000 mg/kg.Justification for classification or non-classification
The substance is currently classified in Annex I of Directive 67/548/EEC as :-
Harmful, Xn R22, Harmful if swallowed
and in Annex VI (Table 3.1) of CLP-Regulation (EC) No 1272/2008 as :-
Acute Toxicity Category 4, with Hazard Statement H302 (Harmful if swallowed)
From the available data only one value is reported which is outside the range 200 -2000 mg/kg. Therefore, it is concluded that the classification of the substance for acute oral toxicity is :-
Harmful, Xn R22, Harmful if swallowed.
Acute Toxicity Category 4 with Hazard Statement, H302 (Harmful if swallowed).
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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