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Description of key information

Oral toxicity of LAB Sulfonic Acid was examined in rats. Groups of 5 male and 5 female rats were exposed orally to 0, 1250, 1415, 1580, or 1990 mg/kg bw of LAB Sulfonic Acid. The animals were then monitored for 14 days for mortality and clinical signs. Body weights were measured on days 7 and 14, and necropsies were performed at the end of the study. Within approximately 30 minutes of application, symptoms observed included dry skin, diarrhea, squatting attitude, small dark red eyes, ataxia, hypothermia, diuresis, occasional trembling, tumbling, and prone position. Nine animals in the 1580 and 1990 mg/kg doses died. In the other doses, the number of animals that died were 0 and 3 of 10 for the 1250 and 1415 mg/kg doses, respectively. Post mortem sections showed strong hyperemias and swelling, as well as partial damage to the stomach and intestinal mucosae. Also, effects to the stomach, liver, and peritoneum were seen. The tissue sections showed swelling of the gastric mucosa in 3 animals, as well as the growing together of organs of the abdominal cavity with the diaphragm in 2 animals. The resulting LD50value was 1470 mg/kg bw. Based on the results of the acute oral toxicity study, LAB Sulfonic Acid is classified Category 4, harmful if swallowed according to the CLP directive.

No study is required for inhalation exposure (data waiving). In accordance with column 2 of REACH Annex VIII-X, in addition to the oral route, for substances other than gases, an acute toxicity study for at least one other route is required. The choice of the second route will depend on the nature of the substance and the likely route of human exposure. As dermal is the most likely route of exposure and acute dermal toxicity data are available, no data gap for inhalation exposure exists.

Dermal toxicity was examined in a study on LAS (read across). The clipped skin on the backs (approximate 10% of the area) of five male and five female rats were exposed to a dose of 2000 mg/kg LAS (read across) and kept under an occlusive dressing for 24 hours, then observed for another 14 days after the dressing was removed and the skin washed in warm water. The treated areas were examined daily for signs of dermal irritation and assessed according to the standard scoring system for erythema, eschar and oedema. On day 15 all animals were sacrificed and given a macroscopic post-mortem examination of internal organs. No mortality was observed at exposures to 2000 mg/kg of the undiluted test material. There were no signs of systemic reaction. Well defined or slight erythema and slight oedema were observed at all test sites after removal of the occlusive dressings, and these reactions were unresolved before progressive hardening of the skin was first detected on day 4. All test sites were entirely covered by scab formation from day 7. Sloughing from the scabbed skin began at various times between day 7 and day 12 and was completed before test termination. Therefore, results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg and LAS (read across) is not classified for acute dermal toxicity under CLP.

The acute toxicity of LAB Sulfonic Acid was examined via both the oral (LAB Sulfonic Acid) and dermal (LAS, read-across) routes.

Based on the results of the acute oral toxicity study, LAB Sulfonic Acid is classified Category 4, harmful if swallowed according to the CLP directive.

The dermal LD50 is > 2000 mg/kg and LAS (read across) is not classified for acute dermal toxicity under CLP.

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:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Laboratory study from experienced laboratory.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Male and female WISW rats averaging 143 g (male) and 117 g (female) in weight. Animals were marked on the fur and held in groups. They were acclimated for 4 to 8 days prior to testing. Standard diet and water was provided ad libitum. Room temperature was held at 20 ± 1°C, humidity at 60 ± 5%, with a 12/12 hour light/dark cycle.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test duration was 14 days.
Doses:
Doses were 1250, 1415, 1580 and 1990 mg/kg.
No. of animals per sex per dose:
10 - Five of each sex per dose level were tested.
Control animals:
not specified
Details on study design:
Animals were weighed immediately before treatment and at 1, 7 and 14 days. At 6 hours and then daily thereafter all animals were observed for symptoms of toxicity. Autopsies were conducted at test termination.
Statistics:
LD50 by Litchfield and Wilcoxon.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 470 mg/kg bw
95% CL:
> 1 361 - < 1 588
Mortality:
9 animals in the 1580 and 1990 mg/kg dose died. In the other doses, the number of animals that died were 0 and 3 of 10 for the 1250 and 1415 mg/kg doses, respectively.
Clinical signs:
Within approximately 30 minutes of application, symptoms observed included dry skin, diarrhea, squatting attitude, small dark red eyes, ataxia, hypothermia, diuresis, occasional trembling, tumbling, and prone position.
Gross pathology:
Post mortem sections showed strong hyperemias and swelling, as well as partial damage to the stomach and intestinal mucosae. Also, effects to the stomach, liver, and peritoneum were seen. The tissue sections showed swelling of the gastric mucosa in 3 animals, as well as the growing together of organs of the abdominal cavity with the diaphragm in 2 animals.
Conclusions:
The test material is slightly toxic to rats following acute oral exposure.
Executive summary:

Ten rats per dose (five of each sex) were given oral gavage doses of the test material ranging from 1250 to 1990 mg/kg. The resulting LD50 value was 1470 mg/kg.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 470 mg/kg bw
Quality of whole database:
Key study is reliable with restrictions.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
No reliable data.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP laboratory study
Justification for type of information:
Category Approach; test material is reference substance LAS. LAS provides suitable read across for LAB Sulfonic Acids as both form the identical chemical species in aqueous solutions at neutral (physiological) pH, namely, the LAS ion (C10-13 linear alkyl benzene-SO3-) and would be expected to have similar acute toxicity properties.
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CFY (remote Sprague Dawley origin)
Sex:
male/female
Details on test animals and environmental conditions:
Rats were in a weight range of 210 to 239 g prior to dosing on day 1 and approximately six to eight weeks of age. All the rats were acclimated to the experimental environment for a period of 15 days prior to study initiation. Animals were housed in individual metal cages with wire mesh floors. Standard diet and water were provided ad libitum. Each animal was identified by cage number and ear punching.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Test material was a yellow viscous liquid and was applied to an area clipped with electric clippers (approximately 10% of the area) on the backs of 10 rats (five male, five female) at a dose of 2000 mg/kg. The areas were covered with gauze held in place with an impermeable plastic dressing. At the end of 24 hours the dressings were carefully removed and the treated area of skin washed in warm water and blotted dry with absorbent paper.
Duration of exposure:
24 hr
Doses:
2000 mg/kg (undiluted)

No. of animals per sex per dose:
5 male and 5 female
Control animals:
not specified
Details on study design:
Animals were observed soon after dosing and then at frequent intervals for the remainder of day 1. On subsequent days the animals were observed once in the morning and again at the end of the experimental day. The treated areas were examined daily for signs of dermal irritation and assessed according to the standard scoring system for erythema, eschar and oedema. All animals were observed for 14 days after dosing. On day 15 all animals were sacrificed and given a macroscopic post-mortem examination of internal organs.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: undiluted
Mortality:
No mortality was observed exposure to 2000 mg/kg of the undiluted test material.
Clinical signs:
There were no signs of systemic reaction. Well defined or slight erythema and slight oedema were observed at all test sites after removal of the occlusive dressings. These reactions were unresolved before progressive hardening of the skin was first detected on day 4. All test sites were entirely covered by scab formation from day 7. Sloughing from the scabbed skin began at various times between day 7 and day 12 and was completed before test termination.
Body weight:
Low bodyweight gains or loss of bodyweight were recorded for one male and three female rats on day 8. Two of the same females and a third female rat also showed low bodyweight gains between days 8 and 15.
Gross pathology:
All terminal autopsy findings were normal.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal dermal dose was found to be greater than 2000 mg/kg.
Executive summary:

The clipped skin on the backs of five male and five female rats were exposed to the test material under an occlusive dressing for 24 hours and observed for another 14 days. Results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Key study is reliable without restrictions.

Additional information

The acute toxicity of LAB Sulfonic Acid was examined via both the oral (LAB sulfonic Acid) and dermal (LAS, read across) routes of exposure. There is no reliable study on inhalation toxicity. A study on inhalation toxicity of LAS (read across) is not considered reliable (KR = 3) due to questions over the composition of the tested material. The study is included for completeness. In the oral exposure study, mortality was seen at the highest dose levels and the resulting acute oral LD50was 1470 mg LAB Sulfonic Acid/kg. In addition, symptoms observed included dry skin, diarrhea, squatting attitude, small dark red eyes, ataxia, hypothermia, diuresis, occasional trembling, tumbling, and prone position. Post mortem sections showed strong hyperemias and swelling, as well as partial damage to the stomach and intestinal mucosae. Effects to the stomach, liver, and peritoneum were also seen. In the dermal test, no mortality was seen at exposures to 2000 mg LAS/kg. Well defined but slight erythema and slight oedema were observed. According to the CLP guidelines, LAB Sulfonic Acid is a category 4 toxicant based on the oral results (LAB Sulfonic Acid) but is not classified based on dermal results (LAS, read across).


Justification for selection of acute toxicity – oral endpoint
Experimental study

Justification for selection of acute toxicity – dermal endpoint
Experimental study

Justification for classification or non-classification

The acute toxicity of LAB Sulfonic Acid via the oral route was classified as Category 4 due to the relative low toxicity. No effects where observed in acute dermal testing, and LAB Sulfonic Acid is not expected to be an acute dermal toxicant.