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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan. 12, 1977 - Feb. 16, 1977
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed similarly to OECD guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: W.S. Spector, Handbook of Toxicology
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, C10-13-alkyl derivs., calcium salts
IUPAC Name:
Benzenesulfonic acid, C10-13-alkyl derivs., calcium salts

Test animals

Species:
rat
Strain:
other: SPF-Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 92-111 g
- Fasting period before study: 16 hrs
- Housing: plastic cages
- Diet (e.g. ad libitum): Haltungsdiat ALTROMIN 1324, ad libitum
- Water (e.g. ad libitum): ad libitum

IN-LIFE DATES: From: Jan. 12, 1977 To: Feb. 16, 1977

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 25% aqueous solution
Doses:
2500, 3200, 5000, 6300 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighed weekly
- Necropsy of survivors performed: yes
Statistics:
LD50 was determined using Probit Analysis (method of Linder and Weber), confidence limits were computed using Cavalli-Sforza.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
4 445 mg/kg bw
Based on:
act. ingr.
95% CL:
3 913 - 5 051
Mortality:
Animals that died, died 1-3 days after exposure.
Clinical signs:
Animals that died exhibited respiratory distress, stumbling, and lethargy prior to expiring.
Body weight:
Body wieght gain of surviving animals was normal.
Gross pathology:
No abnormal observations in any animals.

Any other information on results incl. tables

Acute Oral Toxicity in Female Rats

Dose (mg/kg)

Mortality (No. of Animals)

2500

0

3200

1

5000

6

6300

10

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is weakly toxic via oral exposure but only at doses exceeding the limit dose.
Executive summary:

Groups of 10 female rats were exposed by oral gavage to doses of 2500, 3200, 5000, and 6300 mg/kg of test substance. The animals were then monitored for the 14 days for mortality, and weighed weekly. The LD50 was determined to be 4445 mg/kg. Surviving animals showed no effects.

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