Ammonium dodecylbenzenesulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

read across to GLP, Guideline study (OECD 402)
considered valid surrogate for ammonium salt

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isopropylamine

EC Number:

200-860-9

EC Name:

Isopropylamine

Cas Number:

75-31-0

IUPAC Name:

propan-2-amine

Details on test material:

- Name of test material (as cited in study report): Isopropylamine
- Physical state: liquid
- Analytical purity: 99.9 %
- Lot/batch No.: 561211
- Storage condition of test material: refrigerator

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. THOMAE GmbH, Biberach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: Animals of comparable weight (200 - 300 g)
- Housing: singly in stainless stell wire mesh cages, Type DK-III
- Diet: KLIBA-Labordiaet 343, Klingenthalmuehle AG, Switzerland, ad libitum
- Water: water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: aqua bidest

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 cm2
- Type of wrap if used: Four layers of absorbent gauze


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


TEST MATERIAL
- Concentration (if solution): 10 %

Duration of exposure:

24 h

Doses:

400 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Several times at the day of application and at least once daily therafter.
- Frequency of weighing: Shortly before application, weekly thereafter and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 400 mg/kg bw

Based on:

act. ingr.

Remarks:

(10% dilution in water because of corrosivity)

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

400 mg/kg bw

Based on:

act. ingr.

Remarks:

(10% dilution in water because of corrosivity)

Mortality:

No mortality occurred.

Clinical signs:

On the day of application the animals showed the following syptoms: dyspnoea, apathy, staggering, spastic gait, tremor, piloerection, exophthalmos and poor general state.

Body weight:

mean body weight:
male: 248 g, 298 g, 327 g (day 0, day 7, day 13);
female: 218 g, 233 g, 247 g (day 0, day 7, day 13);

Gross pathology:

Sacrificed animals:
Organs: no pathologic findings noted.
Skin: full thickness necrosis (4 males/4 females), superficial necrosis (1 female), superficial crust formation (1 male)

Any other information on results incl. tables

The acute dermal LD50 of the test material was found to be greater than 400 mg/kg bw for the male und female animals. There is indication that the test material causes local irritation to exposed tissues.

Applicant's summary and conclusion

Interpretation of results:

other: the LD50 is higher than 400 mg/kg bw

Conclusions:

The dermal LD50 of isopropylamine is higher than 400 mg/kg bw. No further doses were tested. With lack of further information, this would put the substance on a classification category of Acute Tox.3, H311 Toxic in contact with skin.