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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:
weight of evidence
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG (Hoe: WISKf(SPF71)
- Age at study initiation: 6-7 weeks (male), 7-8 weeks (female)
- Fasting period before study: approximately 16 hours
- Housing: Macrolon cages (type 4)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: approximately 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: recommended vehicle for this type of study



Doses:
2000 mg/kg bw (limit dose)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
Unspecific symptoms like hypoactivity, squatting posture and coat bristling was observed in all animals from 10 - 60 minutes post application. From 1 hour after adminstration onwards no clinical symptoms of toxicity were observed until the end of the observation period.
Body weight:
Not influenced
Gross pathology:
No effects
Interpretation of results:
other: CLP/EU GHS classification criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
EC Number:
263-174-9
EC Name:
Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
Cas Number:
61791-42-2
Molecular formula:
UVCB
IUPAC Name:
Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
Test material form:
semi-solid (amorphous): gel
Remarks:
paste

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, SPF breeding, Hoe:WISK(SPF71)
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 187 g ± 7 g males, 180 g ± females
- Fasting period before study: over night
- Housing: Macrolon cages (type 4)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: approximately 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: recommended

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:
2000 mg/kg bw (limit dose)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No lethality
Clinical signs:
Unspecific symptoms like hypoactivity, squatting posture and coat bristling was observed in all animals from 10 - 30 minutes up to 4 - 6 hours post application. From day 1 until the end of the observation period no symptoms of toxicity were observed.
Body weight:
Not influenced
Gross pathology:
No findings

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS classification criteria not met, no classification required according to Regulation (EC) No. 1272/2008.