Sulfonic acids, C16-alkane hydroxy and C16-alkene, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01. November 1984 to 11. December 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts

Cas Number:

68439-57-6

Molecular formula:

C(4+2n)H(9+4n)SO4Na C(4+2n)H(7+4n)SO4Na n = 5-6

IUPAC Name:

Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Name of test material (as cited in study report): Hostapur OS Pulver; alpha-Olefinsulfonate, sodium salt
- Molecular weight (if other than submission substance): approx. 310
- Physical state: white powder
- Analytical purity: approx. 90 %
- Impurities (identity and concentrations): approx. 5 % Na2SO4, 3 % Na2CO3, 2 % residual oil
- Composition of test material, percentage of components: C-chainlengths: ≤ C12: max. 1 %, C14: approx. 65 %, C16: approx. 30 %, ≥ C18: max. 1.5 %
- Lot/batch No.: E0617179, dated 1984-06-05
- Storage condition of test material: dark at 22°C in fume hood
- Other: Source: Hoechst AG

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding
- Weight at study initiation: males 180 - 205 g (mean 195.4 g); females 161 - 184 g (mean 168.7 g)
- Fasting period before study: 16 hours before and 2 hours after application
- Housing: 5/cage
- Diet (e.g. ad libitum): rat diet Altromin 1324 (Altromin-GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 %
- Amount of vehicle (if gavage): 6.3, 8.0, 10.0, 16.0 ml/kg bw
- Justification for choice of vehicle: water, good solubility


MAXIMUM DOSE VOLUME APPLIED: 16 ml/kg

Doses:

1600, 2000, 2500, 4000 mg/kg bw

No. of animals per sex per dose:

5 (2000 mg/kg bw only 5 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations at 10, 30 and 60 min, 2, 4 and 6 hours, and 1, 2, 3, 4 and 14 daysafter application, weighing was performed weekly (prior to dosing and on day 7 and 14)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, time to lethality

Statistics:

The LD50, 95 % confidence limits and the linear Probit equation were calculated from mortality rates by Probit analysis.
LD50 values were calculated separately for males and femalesas well as combined.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

2 290 mg/kg bw

Based on:

test mat.

95% CL:

> 1 820 - < 3 130

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

2 340 mg/kg bw

Based on:

test mat.

95% CL:

> 1 690 - < 3 270

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 310 mg/kg bw

Based on:

test mat.

95% CL:

> 1 990 - < 2 790

Effect levels 4

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 079 mg/kg bw

Based on:

act. ingr.

95% CL:

> 1 791 - < 2 511

Remarks on result:

other: recalculated to active ingredient

Mortality:

males:
1600 mg/kg bw: 1/5
2500 mg/kg bw: 2/5
4000 mg/kg bw: 5/5

females:
1600 mg/kg bw: 0/5
2000 mg/kg bw: 1/5
2500 mg/kg bw: 4/5
4000 mg/kg bw: 5/5

Clinical signs:

males and females: hunched posture, hollow flanks, lateral position, quiet behaviour, clonic convulsions (weak), negative startle reflex, ruffled fur, cyanosis, hypothermia, closure of palpebral fissure, mucous faeces, irregular and intermittent breathing. Two females temporarily demonstrated increased sensitivity towards touch, two males demonstrated an distended abdomen on day 1 and 2.

Body weight:

No reduction of body weight observed.

Gross pathology:

Macroscopic examination of the deceased animals demonstrated damages of the gastro-intestinal tract. The stomachs were tightly filled with brownish fluid and foam, respectively. The gastric mucosa showed a dark-red colour with sporadical hemorrhages. The mucosae of colon and small intestine showed a dark-red colour, as well, sporadically with hyaline appearance. Blood vessels of the GI-tract were injected.

The animals sacrificed at the end of the observation period did not show any macroscopic changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts in rats was > 2000 mg/kg bw.