Reaction mass of sodium octane-1-sulfonate and disodium octane-1,2-disulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Remarks:

as described by the FDA (21 CFR Part 58), 16 CFR 1500.3 and FDRL Standard Operating Procedures.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium octane-1-sulphonate monohydrate

EC Number:

226-195-4

EC Name:

Sodium octane-1-sulphonate monohydrate

Cas Number:

5324-84-5

Molecular formula:

C8H18O3S.Na

IUPAC Name:

sodium octane-1-sulfonate hydrate

Specific details on test material used for the study:

FDRL Test Article ID: 85-0506
Sponsor Test Article ID: Sample No. 910-77

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA
- Age at study initiation: 'young', not further specified
- Weight at study initiation: 255.4 ± 9.3 (males), 219.4 ± 13.0 (females)
- Fasting period before study: Food was withheld the night prior to dosing
- Housing: Animals were individually housed in wire mesh bottom cages in environment-controlled rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

On the first day of the study, animals received a single oral dose by gavage of the test article at a level of 5.0 g/kg body weight.

Doses:

5 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were weighed prior to dosing and at termination of the study or at necropsy. They were observed frequently on the day of dosing and daily thereafter for a total of 15 days. All external signs of toxicity or pharmacological effects were noted.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

95% CL:

> 0 - < 27

Remarks on result:

other: only one dose tested

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: only one dose tested

Mortality:

0 %; 0 of 10 rats died within the 15 day observation period

Clinical signs:

other: No clinical signs observed. All animals appeared normal throughout the study.

Gross pathology:

no pathology performed

Other findings:

no details given

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute toxicity study in rats no mortality was observed at 5 g/kg bw (LD50 > 5000 mg/kg bw).

Executive summary:

Sodium octane-1-sulphonate monohydrate (EC: 226-195-4; CAS: 5324-84-5) was evaluated for acute oral toxicity in five male and five female Sprague-Dawley rats similar to OECD Guideline 401. The test article was administered by gavage to each of ten rats at a level of 5.0 g/kg body weight. All animals survived the 15 day post-administration observation period. No clinical signs of toxicity were observed during the observation period. Therefore the LD50 value is > 5000 mg/kg bw.