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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
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
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:
No clinical signs observed. All animals appeared normal throughout the study.
Body weight:
males: initial: 255.4 ± 9.3; day 15: 345.8 ±20.8
females: initial: 219.4 ±13.0; day 15: 260.0 ±12.9
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.