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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May - July 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Information from study report:
- Name of test material: Emulgator E30, Fest
- CAS number: 5896-54-8
The CAS number in report (5896-54-8) is misleading, since this CAS number does only represent 1-Penta-decanesulfonic acid, sodium salt (1:1), but it is confirmed that the substance used is correctly assigned to CAS 68188-18-1.
- Appearance/Further information: The test substance was supplied as white wax-like leaf-let and was received at the test institute on March 06, 1991.
- Batch No. of test material: 210291
- Purity: 95 %
- Analysis reference: TGL 39237
- Solubility and stability of the test substance in the solvent/vehicle: The substance is known to be stable in water.

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation (mean): males 179.1 g ± 15.19 g, females 165.1 g ± 5.59 g
- Housing: 2-3 rats per cage, Makrolon type III cages
- Diet and water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE: Water (Ampuwa, Fresenius, Bad Homburg)

APPLICATION VOLUME: 10 mL/kg bw
Doses:
720, 900, 1000, 1440, 1620, 2000 and 2880 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Range-finding: A dose range-finder was conducted with doses from 57.6 to 2250 mg/kg bw with one male and one female rat per dose group. In the range-finding one female exposed to 2250 mg/kg bw died.
- Duration of observation period following administration: 14 days
- Frequency of observations: Once a day; in addition the animals were observed directly after dosing and also 1 hour after dosing.
- Frequency of weighing: Body weights were determined prestudy, on study day 0 (day of administration), and on study days 2, 9 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: Organs showing macroscopic changes were preserved in neutral - buffered 10 % formalin and were available for histopathological examinations.
Statistics:
The LD50 with the 95 % confidence limits was calculated according to Litchfield and Wilcoxon, J. Pharm. Exper. Therap. 96, 99-113, 1949.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 271 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
1 373 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
1 133 mg/kg bw
Mortality:
Number of deaths in each dose group (time of deaths)
Males: 720 mg/kg 0/5, 900 mg/kg 1/5 (after 7 days), 1000 mg/kg 1/5 (after one night), 1440 mg/kg 1/5 (after one night), 1620 mg/kg 2/5 (after one night up to 7 days), 2000 mg/kg 5/5, 2880 mg/kg (by 28 hours), 5/5 (by 28 hours).
Females: 720 mg/kg 0/5, 900 mg/kg 1/5 (after 7 hours), 1000 mg/kg 3/5 (after one night), 1440 mg/kg 3/5 (after 6 to 48 hours), 1620 mg/kg 5/5 (within 24 hours), 2000 mg/kg 5/5 (by 28 hours), 2880 mg/kg 5/5 (by 28 hours).
Clinical signs:
Non-specific signs of toxicity were observed, including general depression, ruffled fur and dyspnoea. These signs tended to persist longer in the higher dosages where animals survived the investigation period.
Body weight:
No particular specific effect was noted in the body weight data.
Gross pathology:
Gross necropsy observations were also non-specific in animals at termination. Rats which died during the first few days after dosing showed gastrointestinal lesions and some other congested organs. The cause of death of these animals might be related to the intestinal lesions. Histopathology was not performed.
Executive summary:

An acute oral toxicity study was conducted according to OECD TG 401 on 5 male and 5 female rats per group receiving each a single dose (gavage administration) of the test substance dissolved in water. Dose groups were 720, 900, 1000, 1440, 1620, 2000 and 2880 mg/kg bw. The animals were observed for signs of intoxication during a 14-days post-exposure period.

Non-specific signs of toxicity were observed, including general depression, ruffled fur and dyspnoea. The signs tended to persist longer in the higher dosages where animals survived the investigation period. Gross necropsy observations were also non-specific in animals at termination. Rats which died during the first few days after dosing showed gastrointestinal lesions and some other congested organs. The cause of death of these animals might be related to the intestinal lesions. Histopathology was not performed.

The LD50 was calculated to be 1271 mg/kg (95 % confidence limit 1104 -1462 mg/kg) for both sexes combined.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 271 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May-June 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study, limited data on details of dermal exposure
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Information from study report:
- Name of test material: Emulgator E30, Fest
- CAS number: 5896-54-8
The CAS number in report (5896-54-8) is misleading, since this CAS number does only represent 1-Penta-decanesulfonic acid, sodium salt (1:1), but it is confirmed that the substance used is correctly assigned to CAS 68188-18-1.
- Appearance/Further information: The test substance was supplied as white wax-like leaf-let and was received at the test institute on March 06, 1991.
- Batch No. of test material: 210291
- Purity: 95 %
- Analysis reference: TGL 39237
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation (mean): males 187 g ± 7.8, females 166 g ± 4.4
- Housing: 2-3 rats per cage, Makrolon type III cages
- Diet and water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): approx. 28-40
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE: - % coverage: The test substance was administered on 10 % of the body surface.

TEST MATERIAL: - For solids, paste formed: yes
The test substance was moistenized with 0.2 mL water (Ampuwa, Fresenius, Bad Homburg, Germany) per animal.
Duration of exposure:
not specified in report
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Once a day, in addition directly after application
- Frequency of weighing: Body weights were determined prestudy, on study day 0 (day of application), and on study days 2, 9 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: Organs showing macroscopic changes were preserved in neutral - buffered 10 % formalin and were available for histopathological examinations.
Statistics:
The obtained data were processed to give mean values and standard errors or deviations.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animal died during the in-life phase.
Clinical signs:
No specific effects were observed during the 14-days observation period. Unspecific irritant effects occurred starting on the first day of application (the dorsal body skin was reddened in all animals). Between the 2nd and the 4th day after application the skin appearance changed to being brownish in colour or to being wrinkled. These changes disappeared between day 8 and 11 p.a.
Body weight:
All rats initially lost weight following exposure to the substance, but recovered and all had gained weight by study conclusion.
Gross pathology:
At necropsy all animals were macroscopically examined and the organs showed some non-specific changes interpreted to be due to the necropsy exsanguination. These alterations were within the normal range of biological variation and no histologic examinations were performed.
Executive summary:

An acute dermal toxicity study was conducted as a limit test according to OECD TG 402 on 5 male and 5 female rats receiving each a single dose of 2000 mg/kg bw (no data on type of coverage) of the test substance moistened with water. The animals were observed for signs of intoxication during a 14-day postexposure period.

All rats initially lost weight after compound exposure, but recovered and all had gained weight by study conclusion. No specific effects were observed during the 14-day period after the application regarding clinical signs. Unspecific irritant effects occurred starting on the first day of application (the dorsal body skin was reddened in all animals). Between the 2nd and the 4th day after application the skin appearance changed to being brownish in colour or to being wrinkled. These changes disappeared between Day 8 and 11 post application. At necropsy all animals were macroscopically examined and the organs showed some non-specific changes interpreted to be due to the necropsy exsanguination. These alterations were within the normal range of biological variation and no histologic examinations were performed. Since no animal died during the study period the LD50 was concluded to be > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw

Additional information

An acute oral toxicity study according to OECD TG 401 conducted with the test substance dissolved in water revealed non-specific signs of toxicity (general depression, ruffled fur, dyspnoea). The signs tended to persist longer in the higher dosages where animals survived the investigation period. Gross necropsy observations were also non-specific in animals at termination. Rats which died during the first few days after dosing showed gastrointestinal lesions and some other congested organs. The cause of death of these animals might be related to the intestinal lesions. Histopathology was not performed.

The LD50 was calculated to be 1271 mg/kg (95 % confidence limit 1104 -1462 mg/kg) for both sexes combined.

No acute inhalation toxicity study is available for the substance.

An acute dermal toxicity study according to OECD TG 402 and conducted as a limit test with the water-moistened test substance revealed initially weight loss and unspecific irritant effects (the dorsal body skin was reddened in all animals). All animals recovered and had gained weight by study conclusion. The changes to the skin disappeared between Day 8 and 11 post application. Since no animal died during the study period the LD50 was concluded to be > 2000 mg/kg bw.

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, Annex I, the substance is classified for acute oral toxicity as Cat. 4 (H302: Harmful if swallowed).

According to Regulation (EC) No 1272/2008, Annex I, no classification is required for acute dermal or inhalation toxicity.