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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: The study is considered relevant, adequate and reliable. There were some deviations from the study guidelines, however these did not affect the conclusions and the validity of the study.
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:
male animals only, 32 days dosing
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate
EC Number:
219-147-9
EC Name:
Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate
Cas Number:
2373-38-8
Molecular formula:
C16H30O7S.Na
IUPAC Name:
sodium 1,4-bis[(4-methylpentan-2-yl)oxy]-1,4-dioxobutane-2-sulfonate
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Aerosol MA-80%, sodium dihexylsulfosuccinate
- Physical state: Clear, viscous liquid (80% solution)
- Analytical purity: 78-80%
- Impurities (identity and concentrations): Not provided
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: BV-1193A NH
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: good stability in aqueous solution
- 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)
Duration of treatment / exposure:
32 days
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0.125 , 0.25 and 0.50% in terms of solids content of the sample
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
0.13, 0.25 and 0.51 g/kg bw/day
Basis:
other: calculated mean daily actual ingested
No. of animals per sex per dose:
10 animals on 3 dosages and 10 animals as control = 40 animals
Control animals:
yes, concurrent no treatment
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 0.125%; 0.25% and 0.5%, respectively, in terms of solids content of the sample. 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 food intake and weight gain that achieved statistical significance at the 0.125% level; however, since significant differences in these respects did not exist at the two higher levels, this observation is considered of no importance. All animals were sacrificed and autopsied at the conclusion of the study, and no pathology attributable to ingestion of the product was found at autopsy.
Mean daily dosage of the product is calculated as 0.13 g/kg, 0.25 g/kg and 0.51 g/kg of solids for the animals at the 0.125%, 0.25% and 0.5% levels, respectively.

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

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

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No

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
Description (incidence and severity):
There were no deaths during this time, and appearance and behavior of the animals at all dosages of the product were normal.
Mortality:
no mortality observed
Description (incidence):
There were no deaths during this time, and appearance and behavior of the animals at all dosages of the product were normal.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
There was a slight reduction in mean weight gain that achieved statistical significance at the 0.125% level; however, since significant differences in these respects did not exist at the two higher levels, this observation is considered of no importance.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
There was a slight reduction in mean food intake that achieved statistical significance at the 0.125% level; however, since significant differences in these respects did not exist at the two higher levels, this observation is considered of no importance.
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Description (incidence and severity):
All animals were sacrificed and autopsied at the conclusion of the study, and no pathology attributable to ingestion of the product was found at autopsy.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
>= 0.5 other: %
Based on:
act. ingr.
Sex:
male
Basis for effect level:
other: No effects observed
Dose descriptor:
NOAEL
Effect level:
>= 510 mg/kg bw/day (actual dose received)
Based on:
act. ingr.
Sex:
male
Basis for effect level:
other: No effects observed

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 MA-80% in the Diet of Male Albino Rats

Concentration in diet,%

0

0.125

0.25

0.50

Number of animals

10

10

10

10

Mean dosage, g/kg/day

--

0.13

0.25

0.51

Mean food intake, g/rat/day

19.6

18.8*

19.0

19.2

Mean weight gain, g/rat

177

165*

169

173

Deaths

0

0

0

0

Mean no. of days to death

--

--

--

--

*Denotes a value significantly lower than control value (< 0.5)

NOTE: “Concentrations in diet” are in terms of the solids content of the sample

Applicant's summary and conclusion

Conclusions:
Feeding the test item for 32 days at concentrations of 0.125%, 0.25% and 0.5% in terms of solids content 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 0.13 g/kg, 0.25 g/kg and 0.51 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:

The test item was added to the diet of three groups of young male albino rats, ten animals per group, in amounts sufficient to give concentrations of 0.125%; 0.25% and 0.5%, respectively, in terms if solids content of the sample. 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 food intake and weight gain that achieved statistical significance at the 0.125% level; however, since significant differences in these respects did not exist at the two higher levels, this observation is considered of no importance. All animals were sacrificed and autopsied at the conclusion of the study, and no pathology attributable to ingestion of the product was found at autopsy.

Mean daily dosage of the product is calculated as 0.13 g/kg, 0.25 g/kg and 0.51 g/kg of solids (active ingredient) for the animals at the 0.125%, 0.25% and 0.5% levels, respectively.