Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
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 403 (inhalation risk test) 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 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
other:
Limit test:
yes

Test material

Constituent 1
Chemical structure
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): Laurylsaeurechlorid
- 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
- Mean weight per trial at study initiation: 171 and 167 g (mixed sexes)
no further details given

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Rats were exposed for 8 h to a vapour saturated atmosphere.
The vapour was generated by bubbling 200 l/h dry air (no CO2) through the liquid substance column (volume ca. 50 ml) of about 5 cm above a fritted glass disc in a glass cylinder. The glass cylinder was heated in a water bath. Temperature in the exposure chamber was 20°C. Nominal concentration was stated in the raw data to be 0.15 mg/L (0.156 mg/l as recalculated from the raw data).
The vapour saturation treshold is calculated to be approx. 0.21 mg/L (at 25°C). Therefor, the test atmosphere should be considered as vapour.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
Nominal concentration was 0.16 mg/L as mean of two trials with 0.11 and 0.21 mg/L, respectively
No. of animals per sex per dose:
6 (3 animals/sex in two trials)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was performed at the start and at the end of the study. Observation was several times at the day of exposure and presumably daily on the following days except on weekends and holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 0.16 mg/L air (nominal)
Exp. duration:
8 h
Remarks on result:
other: No mortality observed within 8 h
Mortality:
No mortality observed
Clinical signs:
other: (Slight) irritations of the mucosa, closed eye lids; reversible within 1 d
Body weight:
Mean body weight after 7 d
1st trial 192 g (weight gain +21 g); 2nd trial 183 g (+17 g)
Gross pathology:
Chronic bronchitis (2x), blown lung (1x)

Applicant's summary and conclusion

Executive summary:

Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions mostly due to reduced reporting in times before GLP. Rats were exposed for 8 h to a vapour saturated atmosphere. nominal concentration was 0.16 mg/L as stated in the raw data. No mortality was reported; observed clinical signs and necropsy findings were irritation effects on the mucosa and blown lung (in one case), respectively.

Conclusion

Inhalation of 0.16 mg/L Lauroyl chloride for 8 h does not represent a lethal inhalation risk.