Lauroyl chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Lauroyl chloride

EC Number:

203-941-7

EC Name:

Lauroyl chloride

Cas Number:

112-16-3

Molecular formula:

C12H23ClO

IUPAC Name:

dodecanoyl chloride

Constituent 2

Reference substance name:

XVIII/195

IUPAC Name:

XVIII/195

Details on test material:

- Name of test material (as cited in study report): Laurinsaeurechlorid
- Physical state: liquid
- Purity: no data
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals

Species:

rat

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: US
- Weight at study initiation: 170 ± 18 g (male), 152 ± 12 (female)

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous emulsion containing Traganth

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2, 20, 30%

MAXIMUM DOSE VOLUME APPLIED: 21.3 ml/kg = maximum 3.94 ml/animal
Maximum dose volumes of 21.3 mL/kg bw (= 3.94 mL/ animal) extend the recommended amounts suggested in the guideline.

Doses:

200, 1600, 3200, 4000 and 6400 µL/kg = ca. 184, 1472, 2944, 3680 and 5888 mg/kg (calculated with a density of 0.92 g/mL)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was only at the beginning of the study for dose calculation. Observation of clinical signs was several times on the day of administration and once daily afterwards except on weekends and on holidays.
- Necropsy of survivors performed: yes

Statistics:

Not performed.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3 220 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3.5 mL/kg bw

Mortality:

200 µL/kg: no mortality
1600 µL/kg: no mortality
3200 µL/kg: 8/20 animals (5m/3f)
4000 µL/kg: 13/20 animals (4m/9f)
6400 µL/kg: 19/20 animals (9m/10f)
Mortality occurred predominantly with in the first 48 h (80%)

Clinical signs:

other: 200 µL/kg: directly after application: piloerection, intermittent respiration; reversible within 1 d 1600 µL/kg: directly after application: squatting posture, piloerection, intermittent, irregular respiration; partly aqueous secretion from the oral cavit

Gross pathology:

Animals that died
Gastrointestinal tract with hemorrhagic content, swollen stomach, strip-like, brightened liver, pinhead-sized brownish area on the kidney surface; liver necroses, areas with mucosa erosions in the stomach (corpus), strong gastrorhagy, ulcerous penetrating inflammation, adhesive-phlogistic inflammation between liver and stomach, snout with serous crust formation
Sacrificed animals
chronic bronchitis, bronchiectasis vicarious emphysem, reduced nutricional status (scrawny)

Applicant's summary and conclusion

Executive summary:

The study was performed comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP. Groups of 10 rats per sex and dose were administered with 200, 1600, 3200, 4000 and 6400 µL/kg of the test substance. The acute LD50 for male and female rats is ca. 3220 mg/kg (= ca. 3500 µL/kg) after oral application. Observed clinical signs were squatting or abdominal posture, irregular respiration and apathy. Caustic effects (gastrorhagy, mucosa errosion, ulcerous inflamation) on the gastrointestinal tract were observed at necropsy.

Conclusion

According to the results of the present study the test substance, Lauroyl chloride is of low toxicity after oral administration (no classification according to EU criteria; acute oral Cat. 5 according to GHS criteria).