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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Remarks:
the tested substance is the acid part of the compound
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Safepharm Standard Test Method Number 513.01
Principles of method if other than guideline:
A group of three fasted males and three fasted females were treated with the starting dose (2000 mg/kg bw). As the females dosed with 2000 mg/kg bw died, a further three fasted males and three fasted females were treated with the dose level 300 mg/kg bw. The test material was administered orally as a solution in distilled water. The animals were observed 1/2, 1, 2, and 4 hours after dosing and then once daily for up to 14 days. Bodyweights were recorded on Day 0 (day of dosing) and on Days 7 and 14 or at death. At the end of the observation period the surviving animals were killed by cervical dislocation and all animals were subject to gross necropsy.
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: compact
Details on test material:
- Name of test material (as cited in study report):Benzene sulfonic acid, C10-16-alkyl derivatives (68584-22-5)
This substance (dodecylbenzene sulfonic acids (CAS# 27176-87-0)) is from the category of LAB Sulfonic Acids, which includes the following three chemicals:
Benzene sulfonic acid, C10-16 alkyl derivatives (CAS# 68584-22-5),
Benzene sulfonic acid, dodecyl (CAS# 27176-87-0), and,
Benzene sulfonic acid, tridecyl (CAS# 25496-01-9).

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
The test material was administered orally as a solution in distilled water. The animals were observed 1/2, 1, 2, and 4 hours after dosing and then once daily for up to 14 days.
Doses:
300,2000
No. of animals per sex per dose:
9
Control animals:
yes
Details on study design:
A group of three fasted males and three fasted females were treated with the starting dose (2000 mg/kg bw). As the females dosed with 2000 mg/kg bw died, a further three fasted males and three fasted females were treated with the dose level 300 mg/kg bw. The test material was administered orally as a solution in distilled water. The animals were observed 1/2, 1, 2, and 4 hours after dosing and then once daily for up to 14 days. Bodyweights were recorded on Day 0 (day of dosing) and on Days 7 and 14 or at death. At the end of the observation period the surviving animals were killed by cervical dislocation and all animals were subject to gross necropsy

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
775 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 value is geometric mean between 300 and 2000 mg/kg bw.
Mortality:
Three females were found dead one day after dosing at the 2000 mg/kg bw dose level. There were no deaths at the 300 mg/kg bw dose level.
Clinical signs:
No clinical signs of toxicity were noted in animals treated with 300 mg/kg bw.
Body weight:
The surviving animals showed expected gains in body weight over the study period.
Gross pathology:
Abnormalities noted at necropsy of animals that died duringthe study were abnormally red lungs, dark liver, and dark kidneys.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral LD50 in male/female rats is 775 mg/kg bw. LD50 value is geometric mean between 300 and 2000 mg/kg.