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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to official guidelines

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
according to guideline
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
according to guideline
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
Cas Number:
Molecular formula:
C49 H49 Cl N2 O6 S2
Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
Identification: V516690 -- Appearance: Brown to green powder -- Batch: V516690/AY -- Purity/Composition: LC-MSpurity (Area% UV-VIS): 95.8% (Reference: PA064492) -- Test item storage: At room temperature stable under storage conditions until 17 July 2016 (expiry date) -- Molecular formula: C49H49ClN2O6S2 -- MW: 861.52

Test animals

Details on test animals or test system and environmental conditions:
The Sprague Dawley SD rat was used, being a species and strain accepted by many regulatory authorities and since there is ample experience and background data. The oral route of administration is a potential route of exposure during manufacturing, handling or use of the substance.

Procedures and facilities were compliant with the requirements of the Directive 2010/63/EU on the protection of animals used for scientific purposes. The national transposition of the Directive is defined in Decreto Legislativo 26/2014.
RTC test facility is fully accredited by AAALAC. Aspects of the protocol concerning animal welfare have been approved by RTC animal-welfare body.

Age & sex: 6-7 weeks old female rats (nulliparous and non-pregnant)
Supplier: Envigo RMS srl, San Pietro al Natisone (UD), Italy
Weight range at arrival: 157.0 - 170.3 grams
Acclimation period: at least 5 days
Veterinary health check during the accimatisation period

Housing: polisulphone solid bottomed cages measuring 59.5 x 38 x 20 cm with nesting material provided into suitable bedding bags
Animals per cage: 3 during the study; up to 5 during the acclimatisation

Administration / exposure

Route of administration:
oral: gavage
CMC (carboxymethyl cellulose)
The test item was dissolved/suspended in a 0.5% aqueous solution of carboxy- methylcellulose.
Details on oral exposure:
Frequency of treatment: Animals were dosed once only on Day 1.
Fasting procedure: Food was removed from the cages overnight prior to dosing (Day -1) and was made available approximately 4 hours after dosing.
Dose calculation: On the day of dosing (Day 1), the amount of the formulated test item to be administered was calculated for each fasted animal according to body weight.
Dosing method: The formulated test item was administered, by gavage, at a dose volume of 20 mL/kg using a plastic feeding tube attached to a graded syringe.
2000 mg/kg
No. of animals per sex per dose:
3 per experiment
Group 1 (step 1): Rat numbers 1, 3, 5
Group 2 (step 2): Rat numbers 7, 9, 11
Details on study design:
Random at arrival. The body weight of each individual was within 20% of the group’s mean.
Animals were unequivocally numbered within the study.
The animal number together with the study number ensured a unique animal numbering for any study employing computerised data collection. The computer system used in this study was Pristima version 6.3.2.

Mortality and morbidity: Throughout the study all animals were checked twice daily.

Clinical signs: Animals were observed for clinical signs as indicated below
Session 2: approximately 0.5 hour after dosing · Session 3: approximately 2 hours after dosing · Session 4: approximately 4 hours after dosing
Daily thereafter for a total of 14 days (Session 1). Body weight
All animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 2, 8 and 15.
Body weight change calculated for Days 2, 8 and 15 of the dosing phase was relevant to Day 1 of the phase.

Termination: All animals were sacrificed on Day 15.
Euthanasia method: Animals were sacrificed by carbon dioxide narcosis.
Necropsy procedure: Necropsy was carried out on all animals (gross necropsy examination for both external and internal abnormalities, with particular attention to the gastro-intestinal tract).

Results and discussion

Effect levels
Dose descriptor:
Effect level:
>= 2 000 other: mg/kg
Based on:
test mat.
No mortality occurred in the first group of animals initially dosed at 2000 mg/kg (Group 1, Step 1) and in the further group of 3 females dosed at the same dose level (Group 2, Step 2).
Clinical signs:
other: No clinical signs were observed in the first group of animals initially dosed at 2000 mg/kg (Group 1, Step 1) and in the further group of 3 females dosed at the same dose level (Group 2, Step 2).
Gross pathology:
No abnormalities were observed at necropsy examination performed on all animals dosed at 2000 mg/kg (Groups 1 and 2) at the end of the observation period.

Applicant's summary and conclusion

The acute toxicity of V516690 was investigated following a single oral administration (20 mL/kg in 0.5% aqueous solution of carboxymethylcellulose) to the Sprague Dawley rat followed by a 14-day observation period. No mortality occurred and no signs of toxicity were observed in the 6 animals following dosing at 2000 mg/kg. These results indicate that the test item V516690 did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following: Classification: not required Signal word: none indicated Hazard statement: none indicated