Registration Dossier
Registration Dossier
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EC number: 215-355-9 | CAS number: 1323-42-8
Endpoint summary
Administrative data
Description of key information
No adverse effects for acute toxicity endpoints.
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
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Documentation is scanty.
- Principles of method if other than guideline:
- Similar to OECD guideline 401.
- GLP compliance:
- not specified
- Remarks:
- Precedes establishment of GLP
- Test type:
- other: Limit test at 5000 mg/kg
- Limit test:
- yes
- Specific details on test material used for the study:
- Substance Name: Paricin 13, GMHS, Glyceryl Monohydroxystearate, CAS#: 1323-42-8, EC#: 215-355-9, IUPAC: 2-hydroxy-1-(hydroxymethyl)ethyl 2-hydroxyoctadecanoate
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- 50% solution
- Doses:
- All rats received a single dose of 5g test material/kg of body weight.
- No. of animals per sex per dose:
- 5 females and 5 males all received one dose each of 5g test material/kg of body weight.
- Control animals:
- no
- Details on study design:
- After all rats were given a dose of 5g test material/kg bw, the animals were observed daily over a 14 day period. Any deaths that occured were recorded.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the 14 day study.
- Clinical signs:
- No clinical symptoms were recorded in the study.
- Gross pathology:
- No gross abnormalities were recorded in the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of the test material is greater than 5000 mg/kg bw in the rat.
Reference
Findings of the study:
|
|
Deaths |
|
|||||||||||||
Dose Level g/kg |
No. Rats Dosed |
Day |
Mortality after 14 Days |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
5.0 |
5 M |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/5 |
5.0 |
5 F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- adequate
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study waived due to provisions of other regulation
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- adequate; waiver applies
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- adequate; waiver applies
Additional information
The LD50 of an acute oral toxicity study is greater than 5000 mg/kg bw. According to Commission Regulation (EU) 2016/863 amending Regulation EC No. 1907/2006, acute testing by the dermal route can be waived if there are no demonstrated acute toxicity, STOT SE, or systemic effects. The test material displayed an acute oral LD50 > 2000 mg/kg bw in rats, is not classified as STOT SE, and shows no systemic toxicity or local irritation. Therefore the substance meets the criteria for waiving the testing requirements for acute dermal toxicity.
Justification for classification or non-classification
The substance shows no acute oral toxicity at 5000 mg/kg bw. This does not meet the criteria for classification for acute toxicity, according to Regulation EC No. 1272/2006. Furthermore, it is not classified as STOT SE, and shows no systemic toxicity or local irritation. Therefore the substance meets the criteria for waiving the testing requirements for acute dermal toxicity according to Commission Regulation (EU) 2016/863 amending Regulation EC No. 1907/2006.
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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