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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1957
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study non-GLP with limited data on study design, however the study was conducted to state of the art methods at that time period. The study is therefore considered adequate, reliable and relevant.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1957
Report date:
1957

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Deviations:
yes
Remarks:
32 days dosing, only males
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate
EC Number:
213-085-6
EC Name:
Sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate
Cas Number:
922-80-5
Molecular formula:
C14H26O7S.Na
IUPAC Name:
sodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate
Constituent 2
Reference substance name:
Sodium diamylsulfosuccinatesodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate
IUPAC Name:
Sodium diamylsulfosuccinatesodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate
Test material form:
other: waxy solid
Details on test material:
- Name of test material (as cited in study report): Aerosol AY
- Physical state: White, waxy solid
- Analytical purity: >97%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not provided
- Purity test date: Not provided
- Lot/batch No.: SPS 900A-MH
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

Test animals

Species:
rat
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
Not provided

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
32 days
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0.25%, 0.50% and 1.00%
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
0.26, 0.51 and 1.00 g/kg bw/day
Basis:
other: calculated mean daily actual ingested
No. of animals per sex per dose:
10 male rats per dose
Details on study design:
The product was added to the diet of three groups of young, male albino rats, ten animals per group, in amounts sufficient to give concentrations of 0.25%, 0.50% and 1.00% respectively. These dietary levels were fed over a period of 32 days.
Mean daily dosage of the product is calculated as 0.26 g/kg, 0.51 g/kg and 1.00 g/kg for the animals at the 0.25%, 0.50% and 1.00% levels, respectively.

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: Not provided

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/rat/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data


OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: No

CLINICAL CHEMISTRY: No

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
There were no deaths during this time, and appearance and behavior of the animals at all dosages of the product were normal. There was a slight reduction in mean weight gain of the group at 0.5% which was significantly lower than that of the controls; however, since this effect was not encountered in the 1% group, the significance of the observation is discounted. All animals were sacrificed and autopsied at the conclusion of the study, and no pathology attributable to ingestion of the product was found by gross examination

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 other: % in the diet
Based on:
act. ingr.
Sex:
male
Dose descriptor:
NOAEL
Effect level:
ca. 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: calculated mean

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Table 1. Summary of Results of 32 Daily Doses of Aerosol AY in the Diet of Male Albino Rats

Concentration in diet, %

0

0.25

0.50

1.00

Number of animals

10

10

10

10

Mean dosage , g/kg/day

-

0.26

0.51

1.00

Mean food intake, g/rat/day

19.6

20.1

18.6

19.0

Mean weight gain, g/rat

177

170

162*

169

Deaths

0

0

0

0

Mean no. of days to death

-

-

-

-

* Denotes a value significantly lower than control value (p<0.05)

Applicant's summary and conclusion

Conclusions:
Feeding of the test item for 32 days at concentrations of 0.25%, 0.50% and 1.0% in the diet of young male albino rats resulted in no significant signs of toxicity. These concentrations are equivalent to mean daily dosages of about 0.26 g/kg, 0.51 g/kg and 1.00 g/kg, respectively. Appearance and behavior of the animals were normal, and at sacrifice and autopsy at the conclusion of the period of feeding, there was no gross pathology that could be attributed to ingestion of the test item.
Executive summary:

Test item containing > 97% active ingredient was added to the diet of three groups of young, male albino rats, ten animals per group, in amounts sufficient to give concentrations of 0.25%, 0.50% and 1.00% respectively. These dietary levels were fed over a period of 32 days. There were no deaths during this time, and appearance and behavior of the animals at all dosages of the product were normal. There was a slight reduction in mean weight gain of the group at 0.5% which was significantly lower than that of the controls; however, since this effect was not encountered in the 1% group, the significance of the observation is discounted. All animals were sacrificed and autopsied at the conclusion of the study, and no pathology attributable to ingestion of the product was found by gross examination. Mean daily dosage of the test item is calculated as about 0.26 g/kg, 0.51 g/kg and 1.00 g/kg for the animals at the 0.25%, 0.50% and 1.00% levels, respectively.