Sodium methyl sulphate

Endpoint summary

Description of key information

LD50, oral, rat > 2000 mg/kg bw (BASF SE, 2017)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan - Feb 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 17, 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: KIRSCHAZ2-00182
- Content: 99.1 g/100 g
- Expiration date of the lot/batch: July 07, 2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: dissolved in deionized water; The test item preparation for each test group was produced shortly before administration by stirring with a magnetic stirrer. The homogeneity of the test item preparation during administration was ensured by stirring with a magnetic stirrer.

FORM AS APPLIED IN THE TEST (if different from that of starting material): dissolved in deionized water

Species:

rat

Strain:

Wistar

Remarks:

SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight (182.8 g))
- Fasting period before administration: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

IN-LIFE DATES: From: 23.01.2017 To: 14.02.2017

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Aqueous preparation corresponds to the physiological medium.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit test; Because no mortality occurred, 2000 mg/kg bw were administered to 3 further female rats in the second step.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 (3 first step + 3 second step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.

Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.

Mortality: A check for any dead or moribund animals was made at least once each workday.

Pathology: Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations.

Histology: No histological examinations were performed.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred in both 2000 mg/kg bw test groups.

Clinical signs:

other: In both test groups no clinical signs were observed during clinical examination.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).

Tab. 1: Mortality

Dose (mg/kg bw):	2000	2000
Sex:	female	female
Administration:	1	2
No. of animals:	3	3
Mortality (animals):	No mortality	No mortality

Tab. 2: Body weights

Individual body weight changes
Dose (mg/kg bw):	2000					2000
Administration:	1					2
Animal No.:	R	R	R	Mean weight	Standard- deviation	R	R	R	Mean weight	Standard- deviation
	52	53	54			68	69	70
Body weight at study day (g):
0	189	182	182	184.3	4.04	178	178	188	181.3	5.77
7	206	207	208	207.0	1.00	198	194	213	201.7	10.02
14	211	213	213	212.3	1.15	230	205	230	221.7	14.43

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg bw in female rats.

Executive summary:

In an acute oral toxicity study performed according to the Acute Toxic Class Method, 2000 mg/kg bw of the undiluted test item were administered by gavage to two test groups of three fasted Wistar rats each (6 females).

Neither clinical signs nor mortality were observed in both test groups dosed with 2000 mg/kg bw.

The body weights of all animals increased within the normal range throughout the study period. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP guideline study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute oral toxicity study performed according to the Acute Toxic Class Method (OECD 423, BASF SE, 2017), 2000 mg/kg bw of the undiluted test item were administered by gavage to two test groups of three fasted Wistar rats each (6 females).

Neither clinical signs nor mortality were observed in both test groups dosed with 2000 mg/kg bw.

The body weights of all animals increased within the normal range throughout the study period. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008.