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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1982-03-06 to 1982-06-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable well-documented study reports which meets basic scientific pronciples.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: 40 CFR Section 772.112-21.
Deviations:
no
Principles of method if other than guideline:
One group of ten (5 male and 5 female) albino rats of the outbred Sprague-Dawley Strain were administered orally to undiluted 5000 mg/kg bw and then observed during 14 days for signs of mortality and toxicity. Individual weights were recorded on the day of dosage, weekly thereafter, and prior to sacrifice.
GLP compliance:
no
Remarks:
the study was conducted prior to the adoption of GLP compliance
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
68608-26-4
Details on test material:
- Molecular formula (if other than submission substance): petroleum derived UVCB substance
- Molecular weight (if other than submission substance):470.69 and 608.95 for two representative structures (please refer to read-across statement)
- Smiles notation (if other than submission substance): for four representative structures:
1) CC(CCC)C(C)CC(C)(C)C(C)C(C)CC(C)c1cc2cc(ccc2cc1)S(=O)(=O)O[Na]
2) O=S(=O)(O[Na])c1ccc2c(c1)C3CCCC3CC2C(C)CC(C)C(CC)C(C)C(C)CC
3) CC(CCCC)C(C)CCC(CC(C)CC(C)C)c2cc1c(cccc1c3CCCc23)S(=O)(=O)O[Na]
4) CC(C)CCC(C)C(C)CC(C(C)C(C)C(C)CCC)C4CC2C(CCC1CCCC12)c3c(cccc34)S(=O)(=O)O[Na]
- Structural formula attached as image file: please refer to read-across statement
- Substance type: organic
- Physical state: liquid
- Other:
- Sample received: 1982-05-12

Test animals

Species:
rat
Strain:
other: outbred albino Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: not reported
- Weight at study initiation: between 200 and 300 g
- Fasting period before study: The rats were deprived of food but not water overnight prior to dosing.
- Housing: Stainless steel with elevated wire mesh flooring 3-5 rats/cage by sex; Tachboard Shepherd Products Company Kalamazoo, Michigan 49005
- Diet (e.g. ad libitum): Wayne Lab-Blox diet ad libitum (except overnight prior to dosing)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 ± 2 °F corresponds to 21°C
- Humidity (%): 45 ± 5
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No details reported
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Each animal was weighed and dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle.
- Duration of observation period following administration: 14 days. Animals were observed frequently on the day of dosage, and twice per day thereafter (morning and afternoon).
- Frequency of observations and weighing: Individual weights were recorded on the day of dosage, weekly thereafter, and prior to sacrifice.
- Necropsy of survivors performed: yes. Gross autopsies were performed on all animals which died during the 14 day observation period and also on all survivors of the 14 day observation period

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no effects
Mortality:
Two deaths (males) occurred within 24 hours. The death of 1 female on day 5 was not preceded by any apparent abnormal clinical signs.
Clinical signs:
All the animals appeared ruffled after 3 hours. The genital area of the surviving animals appeared soiled within 24 hours. Females returned to normal within 48 hours and surviving males within 4 days. The remaining animals continued to appear normal throughout the remainder of the observation period.
Body weight:
The animals gained in body weight (males: 274, 401 and 421 g on day 1, 7 and 14, respectively; females: 237, 282 and 326 g on day 1, 7 and 14, respectively).
Gross pathology:
Lungs, livers and spleen appeared pale and mottled in the anymals dying during the observation period. No remarkable findings attributable to the test material were observed in the other animals sacrificed at the conclusion of the observation period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute LD50 greater than 5000 mg/kg bw was established for male and female rats.
Executive summary:

One group of ten (5 male and 5 female) albino rats of the outbred Sprague-Dawley Strain weighing between 200 and 300 gm was employed in this study. The rats were deprived of food but not water overnight prior to dosing. Each animal was weighed and dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle. The sample was dosed as supplied. The following dosage level was administered: 5.0 gm/kg. Following administration the animals were allowed food and water ad libitum for the 14 day observation period during which time the rats were observed for signs of toxicity and mortalities. Animals were observed frequently on the day of dosage, and twice per day thereafter (morning and afternoon). Individual weights were recorded on the day of dosage, weekly thereafter, and prior to sacrifice. The animals were euthanized at the conclusion of the observation period with carbon dioxide. Gross autopsies were performed on all animals which died during the 14 day observation period and also on all survivors of the 14 day observation period. Two deaths (males) occurred within 24 hours. The death of 1 female on day 5 was not preceded by any apparent abnormal clinical signs. All the animals appeared ruffled after 3 hours. The genital area of the surviving animals appeared soiled within 24 hours. Females returned to normal within 48 hours and surviving males within 4 days. The remaining animals continued to appear normal throughout the remainder of the observation period. The surviving animals animals gained in body weight (males: 274, 401 and 421 g on day 1, 7 and 14, respectively; females: 237, 282 and 326 g on day 1, 7 and 14, respectively). Lungs, livers and spleen appeared pale and mottled in the anymals dying during the observation period. No remarkable findings attributable to the test material were observed in the other animals sacrificed at the conclusion of the observation period. The subject material when studied in male and female albino rats has an acute oral LD50 greater than 5.0 gm/kg.