sodium 3-[(2,3-dicyanophenyl)thio]propane-1-sulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

Study test phase 2013-04-09 to 2013-05-07. Report complete 2013-06-12

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Meets the criteria for classification as Reliable with restrictions according to Klimisch et al (1997). The read-across is based on the hypothesis that the Source and Target substances will have similar toxicological and ecotoxicological properties due to their close physical-chemical and structural similarities. For example, both the Source and Target substances are monoconstituents which share structural similarities and contain the same functional groups (thio ether, sulfonate, vicinal nitrile groups).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

See confidential details on test material section.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK
- Age at study initiation: 8-12 weeks
- Fasting period before study: Overnight fast immediately before dosing
- Housing: In groups of 3 in suspended solid floor polypropylene cages furnished with wooden flakes
- Diet (e.g. ad libitum): Free access to food except for fasting period overnight before dosing and for 3-4 hours after dosing.
- Water (e.g. ad libitum):Free access to water except for fasting period overnight before dosing and for 3-4 hours after dosing.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 300 mg/kg initially and then 2000 mg/kg
CLASS METHOD
- In the absence of data regarding the toxicity of the test item 300 mg/kg was chosen as the starting dose.

Doses:

300 mg/kg and 2000mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and susequently once daily for 14 days. Individual body weights were recorded prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations for signs of systemic toxicity, body weight, mortality

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study

Clinical signs:

No signs of systemic toxicity were noted

Body weight:

All animals showed expected gains in body weight

Gross pathology:

No abnormalities were noted at necropsy

Any other information on results incl. tables

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be >2500 mg/kg body weight (Globally Harmonized Classification Sysytem - Unclassified).

The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Sbstances or Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.

Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the source test item in the Wistar strain rat. The study was designed to be compatible with the following guidelines:

- OECD Guidelines for the Testing of Chemicals No. 423 'Acute Oral Toxicity - Acute Toxic Class Method' (adopted 17 December 2001)

- Method B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008

This read-across is based on the hypothesis that the Source and Target substances will have similar toxicological and ecotoxicological properties due to their close physical-chemical and structural similarities. For example, both the Source and Target substances are monoconstituents which share structural similarities and contain the same functional groups (thio ether, sulfonate, vicinal nitrile groups).

Results

Mortality - There were no deaths

Clinical Observations - No signs of systemic toxicity were noted

Bodyweight - All animals showed expected weight gains

Necropsy - No abnormailites were noted

Conclusion

The acute oral median lethal dose (LD50) of the source test material in the female Wistar strain rat was estimated to be >2500 mg/kg body weight (Globally Harmonized Classification Sysytem - Unclassified).

The source test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances or Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.