Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well-documented journal publication.

Data source

Reference

Reference Type:

publication

Title:

Toxicologic Studies with Branched and Linear Alkyl Benzene Sulfonates in Rats

Author:

Oser, BL, and Morgareidge, K

Year:

1965

Bibliographic source:

Toxicology and Applied Pharmacology 7, 819-25

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Fitzhugh, OG, and Schouboe, PJ. (1959). Subacute toxicity. In: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. pp. 26-35. Assoc. of Food and Drug Officials of the US, Bureau of Food and Drugs, Texas State Dept. Of Health, Austi

GLP compliance:

no

Remarks:

Study was done in 1965 prior to implementation of GLP.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

ABS

IUPAC Name:

ABS

Constituent 2

Reference substance name:

LAS

IUPAC Name:

LAS

Details on test material:

This study compared the toxicity of branched alkyl benzene sulfonates (ABS) to that of linear alkyl benzene sulfonates (LAS).

ABS:
- Physical state: off-white powder
- Impurities (identity and concentrations): petroleum ether-soluble 0.9%, sodium sulfate 10.5%, water 2.2%
- Composition of test material, percentage of components: 87.1% active ABS, average molecular weight 347, average chain length 12

LAS:
- Physical state: yellow viscous liquid
- Impurities (identity and concentrations): free alkali 0.05%, sodium sulfate 8.8%, water 50.9%
- Composition of test material, percentage of components: 39.5% active ABS, average molecular weight 346, average chain length 12

Test animals

Species:

rat

Strain:

other: albino FDRL

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: weanling
- Housing: individually in wire-mesh cages
- Diet (e.g. ad libitum): ad libitum, Purina Laboratory Chow
- Water (e.g. ad libitum): ad libitum, tap water

Administration / exposure

Route of administration:

oral: feed

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

12 weeks

Frequency of treatment:

Daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0.05, 0.25 g/kg/day
Basis:
nominal in diet

No. of animals per sex per dose:

15 of each sex

Control animals:

yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations: appearance, behaviour, and overt signs of toxicity

BODY WEIGHT: Yes
- Time schedule for examinations: weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, half of animals of each sex
- Time schedule for examinations: weekly

HAEMATOLOGY: Yes, half of animals of each sex
- Time schedule for collection of blood: weeks 6 and 12
- Parameters checked: hemoglobin, hematocrit, total and differential leucocyte count, blood glucose, and urea nitrogen

URINALYSIS: Yes, half of animals of each sex
- Time schedule for collection of urine: weeks 6 and 12
- Parameters checked: albumin, pH, glucose, microscopic examination of sediment

Sacrifice and pathology:

GROSS PATHOLOGY: Yes, all animals
liver, kidneys, spleen, heart, adrenals, pituitary, and cecum were weighed

HISTOPATHOLOGY: Yes, 5 rats of each sex in control and high dose groups, all animals of the low dose group though only the liver spleen, stomach, kidneys, and cedum of this group was examined.
liver, spleen, stomach, small intestine, large intestine, pancreas, kidney, bladder, adrenal, gonads, thyroid, pituitary, thymus, salivary gland, lymph node, heart, lung, femoral marrow, aorta, muscle, spinal cord, brain

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Mortality:

mortality observed, treatment-related

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

no effects observed

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Details on results:

CLINICAL SIGNS AND MORTALITY
Occasional signs of wetting in the ventral regions of females in the high dose ABS and high dose LAS groups.

BODY WEIGHT AND WEIGHT GAIN
Body weight gain was normal in all groups.

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Normal in all groups.

FOOD EFFICIENCY
Normal in all groups.

HAEMATOLOGY
Normal in all groups.

CLINICAL CHEMISTRY
Normal in all groups.

URINALYSIS
Normal in all groups.

ORGAN WEIGHTS
Increased liver weights were noted in females in the high dose LAS group, and in both sexes in the high dose ABS group. Increased cecal weights were noted in the high dose male ABS group.

GROSS PATHOLOGY
No treatment related changes noted.

HISTOPATHOLOGY: NON-NEOPLASTIC
No dose related changes noted.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

50 mg/kg bw/day (nominal)

Based on:

act. ingr.

Sex:

male/female

Basis for effect level:

other: ABS: increased liver weight in both sexes LAS: increased liver weights in females, and increased cecal weights in males

2

Dose descriptor:

LOAEL

Effect level:

250 mg/kg bw/day (nominal)

Based on:

act. ingr.

Sex:

male/female

Basis for effect level:

other: ABS: increased liver weight in both sexes LAS: increased liver weights in females, and increased cecal weights in males

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Body Weight Gain and Organ Weights

	Control	0.05 g/kg ABS	0.25 g/kg ABS	0.05 g/kg LAS	0.25 g/kg LAS
Body Weight Gain
Females (g)	169	168	152	164	163
Males (g)	313	298	315	315	314
Liver Weight
Females (%)	3.86	3.98	4.67	3.77	4.34
Males (%)	3.58	3.76	4.02	3.81	3.79
Cecal Weights
Females (%)	0.58	0.64	0.65	0.57	0.58
Males (%)	0.47	0.45	0.57	0.49	0.50

Applicant's summary and conclusion

Conclusions:

The 12-week NOAEL for both ABS and LAS was 50 mg/kg/day. The 12-week LOAEL for both ABS and LAS was 250 mg/kg/day.

Executive summary:

Groups of 15 male and 15 female rats were fed doses of 0, 50, or 250 mg/kg/day of ABS or LAS in the diet. Exposure lasted 12 weeks. Animals were observed daily for clinical signs. Body weights were taken weekly. Blood and urine analyses were done at week 6 and 12 of exposure. At the end of the exposure period, all animals were sacrificed and gross pathology and histopathology exams performed. Rats of both sexes in the high dose ABS groups showed increased liver weights. Female rats in the high dose LAS group also showed increased liver weights. Males in the high dose LAS group showed increased cecal weights. Based on these endpoints, the 12 week NOAEL for both ABS and LAS was 50 mg/kg/day. The 12 week LOAEL for both ABS and LAS was 250 mg/kg/day.