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Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1964-10-24 to 1965-03-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Acceptable, sufficiently documented study performed before implementation of corresponding international guidelines which meets basic scientific principles. However, only two animals included in each dose group, therefore it is adequate for classification.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report date:
1965

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the safety of chemicals in foods, drugs and cosmetics of the association of food and drug officials of the United States 1959
GLP compliance:
no
Remarks:
study performance before implementation of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate
EC Number:
247-873-6
EC Name:
Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate
Cas Number:
26650-05-5
Molecular formula:
C17H29NO8S.2Na
IUPAC Name:
disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate
Details on test material:
- Name of test material (as cited in study report): SBU 185 (50 % aqueous solution)
- Substance type: Sulfosuccinate (tensio-active)
- Physical state: Aqueous solution
- Analytical purity: Not provided
- Impurities (identity and concentrations): Not provided
- Lot/batch No.: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided
- Other: the registered trade mark for SBU 185 in Germany is Steinazid SBU 185, in Great Britain: Loramine SBU 185

Test animals

Species:
rabbit
Strain:
other: Albino
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): ad libitum, standardised laboratory diet supplemented with vitamin C
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

Administration / exposure

Type of coverage:
open
Vehicle:
water
Details on exposure:
see Details on study design
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
20 applications (no treatment during the weekends); applicated test material was not washed off
Frequency of treatment:
daily, except during the weekends
Doses / concentrationsopen allclose all
Dose / conc.:
0.357 other: mL/kg bw
Remarks:
nominal per unit body weight
Dose / conc.:
0.714 other: mL/kg bw
Remarks:
nominal per unit body weight
Dose / conc.:
1.428 other: mL/kg bw
Remarks:
nominal per unit body weight
No. of animals per sex per dose:
2 (1 male, 1 female)
Control animals:
yes, sham-exposed
Details on study design:
A total of 8 healthy albino rabbits was used for this test. 3 dose levels 0.357 mL/kg, 0.714 mLkg and 1.428 mL/kg of SBU 185 (50 % aqueous solution; 24.5% act. ingr. minimum) were used. An area of approximately 10% of the total body surface of the animals on the back was clipped free of hair. In each dosage group one animal's skin remained intact, the other animal's skin was abraded. The test substance was applied by gentle inunction, using a glass rod. A total of 20 applications was performed. Applications were made every day except during the weekends. The controls were prepared and treated in the same way, but no SBU 185 was used. Readings of the skin reactions were done daily during the period of the 20 applications. The skin reactions were evaluated according to the following table:

Evaluation of skin reactions:
- Erythema and Eschar Formation
No erythema: score 0
Very slight erythema (barely perceptible): score 1
Well defined erythema: score 2
Moderate to severe erythema: score 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): score 4
Total possible erythema score: 4

- Edema Formation
No edema: score 0
Very slight edema (barely peroeptible): score 1
Slight edema (edges of area well defined by definite raising): score 2
Moderate edema (raised approximately 1 mm): score 3
Severe edema (raised more than 1 mm and extending beyond area of exposure): score 4
Total possible edema score: 4

Furthermore, the animals were observed for a two-week period, following final exposures. During the test and the observation period body weights, food consumption, and behavior were checked daily. Urine was checked at the beginning and at the end of the total test for the presence of protein, reducing substances, blood pigments or any abnormality in gross appearance. Also observations for changes in blood morphology were made. Microscopic examinations were made of the tissues of 1 animal each of the group with the lowest and highest dose level.
Positive control:
no

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily

BODY WEIGHT: Yes
- Time schedule for examinations: daily

FOOD CONSUMPTION: Yes
- Time schedule for examinations: daily

FOOD EFFICIENCY: No

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: at study start and at the end of the post application observation period

CLINICAL CHEMISTRY: No

URINALYSIS: Yes
- Time schedule for collection of urine: at study start and at the end of the post application observation period

NEUROBEHAVIOURAL EXAMINATION: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes, liver, kidneys, spleen, skin untreated and skin untreated
Other examinations:
no
Statistics:
no

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
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 examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
not examined
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not examined
Details on results:
The skin reactions observed show that SBU 185 (50 % aqueous solution) causes in all dose levels after 20 applications a mild to moderate irritation with erythema scores 0.1 to 3 but no edema.

No dose related effects on body weight gain and food consumption.

The urine and blood data show no significant deviations from the norms, respectively between the initial and final readings.

Neither the macroscopical nor the microscopical histopathological examination of the tissues of 1 animal each of the group with the lowest and highest dose level revealed any serious damage. The treated skin of the animal treated with 1.428 mL SBU 185 (50 % aqueous solution)/kg bw showed slight hyperkeratosis and slight chronical inflammation in the stratum papilare.

Effect levels

open allclose all
Dose descriptor:
LOEL
Remarks:
dermal
Effect level:
0 other:
Based on:
test mat.
Remarks:
50% aqueous solution
Dose descriptor:
LOEL
Remarks:
dermal
Effect level:
89 mg/kg bw/day
Based on:
act. ingr.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

In a repeated dermal dose toxicity study in rabbits dose levels of 0.357, 0.714 and 1.428 mL/kg SBU 185 (50 % aqueous solution) were applied in two animals per dose group on an area of approximately 10% of the total body surface (back). One animal's skin remained intact, the other animal's skin was abraded. Readings of the skin reactions were done daily during the period of the 20 applications. The skin reactions were evaluated comparable to Draize. Furthermore, the animals were observed for a two-week period, following final exposures. During the test and the observation period body weights, food consumption, and behavior were checked daily. Urine was checked at the beginning and at the end of the total test for the presence of protein, reducing substances, blood pigments or any abnormality in gross appearance. Also observations for changes in blood morphology were made. Microscopic examinations were made of the tissues of 1 animal each of the group with the lowest and highest dose level.

The skin reactions observed show that SBU 185 (50 % aqueous solution) caused a mild to moderate irritation with erythema scores 0.1 to 3 but no edema at all dose levels.

No dose related effects on body weight gain and food consumption were observed.

The urine and blood data showed no significant deviations from the norms, respectively between the initial and final readings.

Neither the macroscopical nor the microscopical histopathological examination of the tissues of 1 animal each of the group with the lowest and highest dose level revealed any serious damage. The treated skin of the animal treated with 1.428 mL SBU 185 (50 % aqueous solution)/kg bw showed slight hyperkeratosis and slight chronical inflammation in the stratum papilare.

Solid content of SBU 185 according to producers information: minimum 49 %. Taking this value into account, solid content of the 50 % test solution was 24.5 % in minimum.

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