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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:
1959-12-02 till 1959-12-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited reporting. CoA not included in report. Studies performed in the 1950-1960 era did not have details of test material routinely stated in final reports.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report Date:
1959

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Please see remarks below
Principles of method if other than guideline:
Limited reporting.
- 1 sex
- Acclimatisation period unknown.
- 3 to 4 hours fasting.
- Maximum volume of liquid was 33,33 ml/kg.
- Housing conditions are unknown.
- Observation period was 7 days.
- An assumption about a no tested dose level (31600 mg/kg) is made.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
- Physical state: Solid, Powder (color: light-brown)
- Analytical purity: no info
- Impurities (identity and concentrations): no info
- Composition of test material, percentage of components: active ingredient is considered to be 100%
- Purity test date: no info
- Lot/batch No.: no info
- Expiration date of the lot/batch: no info
- Radiochemical purity (if radiolabelling): no info
Specific details on test material used for the study:
Trade name: Petro S (100% high nonene Naphthalene sulphonates)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: male albino rats, Sprague-Dawley strain
- Age at study initiation: no info
- Weight at study initiation: Weight range 97 to 120 grams
- Fasting period before study: 3 to 4 hours
- Housing: housed by groups in metal cages suspended above the droppings
- Diet (e.g. ad libitum): available at all times
- Water (e.g. ad libitum): available at all times
- Acclimation period: no info


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no info
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: no info

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.1, 1.0, 10.0, 30.0 weight/volume solution of test material in distilled water

MAXIMUM DOSE VOLUME APPLIED: 33.33 ml/kg
Doses:
Dose levels:
31.6 mg/kg
100 mg/kg
316 mg/kg
1000 mg/kg
3160 mg/kg
10000 mg/kg
in 0.1, 1.0, 10.0, 30.0 w/v solution of test material in distilled water
No. of animals per sex per dose:
5 male rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observations immediately after administration, 1, 4 and 24 hours on the day of administration, and daily thereafter. Weighing of survivors at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical and behavioral signs, body weight, histopathology
Statistics:
The moving average method was used to calculate the LD50 value (Horn, H.J., Biometrics 12, 311, 1956).

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
4 470 mg/kg bw
95% CL:
2 820 - 7 080
Mortality:
- Dose level 31.6, 100, 316, 1000 mg/kg: no animal died.
- Dose level 3160 mg/kg: 1 animal died within 24 hours.
- Dose level 10000 mg/kg: 5 animals died within 24 hours.
The assumption of total mortality at the 31600 mg/kg dosage level is made.
Clinical signs:
Dosage levels of:
- 31.6 mg/kg bw: normal appearance and behavior
- 100 mg/kg bw: normal appearance and behavior
- 316 mg/kg bw: normal appearance and behavior
- 1000 mg/kg bw: normal appearance and behavior
- 3160 mg/kg bw: immediately following administration normal appearance and behavior. At the 1-hour interval inactivity and labored respiration, ataxia and sprawling of the limbs. At the 4-hour interval ptosis and depressed righting and placement reflexes. At the 24-hour interval animals exhibited inactivity and with an additional day surviving animals appeared to have recovered.
- 10000 mg/kg bw: within 10 minutes the animals exhibited depression characterized by inactivity, labored respiration, ataxia, and sprawling of the limbs. Furthermore, ptosis and depressed righting and placement reflexes.
Body weight:
The average body weight of the surviving animals at each dosage level showed an increase over the respective initial average body weight, which was within normal range of values for rats of the sex, age, and strain used in this study.
Gross pathology:
Gross autopsies performed on the animals which died showed congestion of the lungs, kidneys, and adrenals, and irritation of the gastrointestinal tract. Gross autopsies perfomed at termination revealed no observable gross pathology.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of the test item for male albino rats is 4470 mg/kg of body weight, with confidence limits from 2820 to 7080 mg/kg.
Executive summary:

There was limited reporting.

The study was performed with similarities to OECD Guideline 401 (Acute Oral Toxicity), but not according to GLP standards.

The test material was evaluated for its acute oral toxicity potential in albino rats when administered as gavage doses at levels of 31.6, 100, 316, 1000, 3160 and 10000 mg/kg to males. No mortality occured in animals dosed at the 31.6, 100, 316 and 1000 mg/kg level. At dose level 3160 mg/kg 1/5 animal died and all (5/5) animals died at the 10000 mg/kg level. Clinical signs of toxicity included depression, ptosis and depressed righting and placement reflexes. Gross pathologic examination on the animals that died showed congestion of the lungs, kidneys and adrenals, and irritation of the gastrointestinal tract. Gross pathologic examination at termination revealed nothing remarkable.

Conclusion: The acute oral LD50 of the test item for male albino rats is 4470 mg/kg of body weight, with confidence limits from 2820 to 7080 mg/kg.

According to GHS the substance is classified as toxicity category V.