Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 247-570-9 | CAS number: 26266-63-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Tetrahydrophthalic anhydride
- EC Number:
- 247-570-9
- EC Name:
- Tetrahydrophthalic anhydride
- Cas Number:
- 26266-63-7
- Molecular formula:
- C8H8O3
- IUPAC Name:
- tetrahydro-2-benzofuran-1,3-dione
- Test material form:
- solid - liquid: suspension
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Sample from production lot
- Lot/batch No.of test material: Lab sample of October 9th 2015
- Expiration date of the lot/batch: 2016-10-08
- Purity: 99.91%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient conditions
- Stability under test conditions: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS srl, San Pietro al Natisone, Italy
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation: 168 - 233 g
- Fasting period before study: Overnight prior to dosing and for approximately 4 hours following dosing
- Housing:Group caged in solid bottomed cages
- Diet (e.g. ad libitum): Commerical rodent diet, ad libitum
- Water (e.g. ad libitum): Municipal supply drinking water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 deg C
- Humidity (%): 40 - 70%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2016-09-21 To: 2016-11-04
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30, 200 and 500 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): Test substance dissolved/suspended in vehicle on a w/v basis
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As specified by test guidelines - Doses:
- 5000 mg/kg
2000 mg/kg
300 mg/kg - No. of animals per sex per dose:
- 1 at 5000 mg/kg
3 at 2000 mg/kg
6 at 300 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - at least daily; Weighing - weekly
- Necropsy of survivors performed: Yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 5000 mg/kg - 100% (1/1)
2000 mg/kg - 67% (2/3)
300 mg/kg - 0% (0/6) - Clinical signs:
- other: 5000 mg/kg - Piloerection and hunched posture 2000 mg/kg - Piloerection, hunched posture, reduced activity and part-closed eyes 300 mg/kg - No clinical signs of treatment
- Gross pathology:
- No abnormalities noted
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute toxicity of tetrahydrophthalic anhydride (tTHPA) has been investigated following a single oral administration to the rat.
Mortality was observed in animals following dosing at 5000 and 2000mg/kg. No mortality occurred and no signs of toxicity were observed following dosing at 300mg/kg. - Executive summary:
The acute toxicity of tetrahydrophthalic anhydride (tTHPA) has been investigated following a single oral administration to the rat.
Mortality was observed in animals following dosing at 5000 and 2000mg/kg. No mortality occurred and no signs of toxicity were observed following dosing at 300mg/kg.
Based on these findings the substance should be classified in Category 4 according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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.
