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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP laboratory study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Branched CaDDBS

IUPAC Name:

Branched CaDDBS

Details on test material:

Calcium bis(tetrapropylenebenzenesulphonate); CAS No. 11117-11-6

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 colony
- Age at study initiation: males, approx. 7 weeks; females, approx. 8 weeks
- Weight at study initiation: males, mean = 197 g; females, mean = 193 g
- Fasting period before study: yes
- Housing: Makrolon Type 4 cages on soft wood granulate in groups of 5 animals in fully air-conditioned rooms
- Diet (e.g. ad libitum): ad libitum, Atlromin 1324 rat diet
- Water (e.g. ad libitum): ad libitum, tap water in plastic bottles
- Acclimation period: Not necessary

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 C
- Humidity (%): 55 +/- 20%
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): 12:12 dark:light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: sesame oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 30 cm2
- Type of wrap if used: aluminum foil held in place with an elastic plaster bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Concentration (if solution): 25, 40 and 50% for doses 1000, 1600 and 2000 mg/kg bw, respectively
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

1000, 1600, and 2000 mg/kg bw

No. of animals per sex per dose:

5 males for each of the 1000 and 1600 mg/kg bw doses; 5 males and 5 females for the 2000 mg/kg bw dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms and lethality recorded twice per day (morning and afternoon) on weekdays and once daily on weekends and holidays. Animals found dead were dissected as soon as possible and examined fro macroscopically visible changes. During the observation period the animals were weighed weekly.
- Necropsy of survivors performed: yes. Surviving animals were sacrificed at the end of the observation period, dissected, and examined for macroscopically visible changes.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 1 600 mg/kg bw

Based on:

test mat.

Mortality:

Mortality was observed at doses of 1600 and 2000 mg/kg bw, but not at 1000 mg/kg bw (see table). Lethality was noted only up to day three of the study.

Clinical signs:

other: Besides unspecific symptoms, the animals showed impairments of respiration, motility and reflexes. They also exhibited stupor, prone position, trembling, hypothermia, narrowed palpebral fissures, and blood-encrusted snouts. These symptoms disappeared in

Gross pathology:

At necropsy, blood in the intestinal tract and diffuse reddening of the stomach mucosa were observed in animals found dead. Light or dark discolorations of the liver occurred in two dead male animals of the 2000 mg/kg bw group. No macroscopically visible changes were observed in surviving animals that were sacrificed at the end of the observation period.

Any other information on results incl. tables

Dose mg/kg bw	Lethality
	Male		Female
	Number	Percent	Number	Percent
1000	0/5	0	-	-
1600	5/5	100	-	-
2000	4/5	80	3/5	60

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of phenylsulfonat CA is between 1000 and 1600 mg/kg bw.

Executive summary:

The acute dermal toxicity of Branched CaDDBS (Phenylsulfonat CA) was tested in male and female Wistar rats at doses of 1000, 1600 and 2000 mg/kg bw. Lethality was observed in the 1600 and 2000 mg/kg bw doses but not in the 1000 mg/kg bw dose. All lethality had occurred by day three of the post application observation period. Other signs of toxicity included impairments of respiration, motility and reflexes, as well as stupor, prone position, trembling, hypothermia, narrowed palpebral fissures, and blood-encrusted snouts, all of which had disappeared by eight days post application. The skin showed erythema, fine and coarse scales, desquamations and scars, as well as discoloration, induration, chapping, scabbing and lumpiness. No effects on body weight gain were observed. The resultant acute dermal LD50 is >1000 and <1600 mg/kg bw.