Registration Dossier

Administrative data

Description of key information

No death occurred at concentrations up to 3850 mg/kg. The LD50 value is > 5000 mg/kg. Therefore the test substance is considered to be low toxicity after oral administration. No death occurred when animals are exposed to a saturated atmosphere of stearoyl chloride for 8 h. The inhalation of a saturated atmosphere represents no acute hazard. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Adult laboratory rats were purchased from a breeder. Usually the source and strain of the animals were not documented. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in a suitable vehicle. The concentrations of these preparations were usually adjusted to achieve comparable volumes (e.g. 10 ml) per kg body weight.
Group-wise documentation of clinical signs was performed over the 14- day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. More details e.g. on substance preparation, or dose and time dependence of symptoms, can be inferred from the German hand written raw data.
On the basis of the observed lethality, the LD50 value was determined by probit analysis.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100%, 76,6%, 43 %, 20 %, 9,3 %
- Justification for choice of vehicle: low toxicity, stability and soulubility of the test subsance

MAXIMUM DOSE VOLUME APPLIED:
1,56 ml

Doses:
464, 1000, 2150, 3830, 5000, 6810, 8250 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations: <15 min; 15 min 30 min, 1 h, 2 h, 4 h, 5 h post administration on the day of administration , once daily thereafter except on weekends and holidays
Weighing: prior to administration, on day 7 and at termination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Probit analysis
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 783 mg/kg bw
95% CL:
>= 5 047 - <= 6 570
Mortality:
no mortality occorred in doses up to 3830 mg/kg (details see table below)
Clinical signs:
Apathy, ataxia, tremor, irregular respiration, abdominal posture, poor general condition (details see table below)
Body weight:
Overall body weight development was positiv in all groups (details see table below)
Gross pathology:
5000, 6810, 8250 mg/kg: stomach ulcer, bloody stomach, necrotic stomach mucosa, diarrhea
464, 1000, 2150, 3830 mg/kg: nothing abnormal detected

Dose

[mg/kg]

Mortality

Clinical observation

       

Mean body weight

[g]                

8250

5/5 male     5/5 female

Apathy, ataxia, tremor, irregular respiration, abdominal posture, poor general condition

Beginning: 180 g (male) ;    160 g (female)

Day 7: -

Day 14: -

6810

3/5 male     3/5 female

Apathy, ataxia, tremor, irregular respiration, poor general condition

Beginning: 190 g (male) ;   160 g (female)

Day 7:      210 g (male) ;   186 g (female)

Day 14:     238 g (male) ;   203 g (female)

5000

1/5 male     2/5 female

Apathy, ataxia, irregular respiration, poor general condition

Beginning: 230 g (male) ;   180 g (female)

Day 7:      254 g (male) ;   205 g (female)

Day 14:     260 g (male) ;   230 g (female)

3830

0/5 male     0/5 female

Nothing abnormal detected

Beginning: 190 g (male) ;   160 g (female)

Day 7:      255 g (male) ;   188 g (female)

Day 14:    295 g (male) ;   199 g (female)

2150

0/5 male     0/5 female

Nothing abnormal detected

Beginning: 200 g (male) ;   170 g (female)

Day 7:      269 g (male) ;   211 g (female)

Day 14:     301 g (male) ;   226 g (female)

1000

0/5 male     0/5 female

Nothing abnormal detected

Beginning: 200 g (male) ;   170 g (female)

Day 7:      247 g (male) ;   209 g (female)

Day 14:     298 g (male) ;   219 g (female)

464

0/5 male     0/5 female

Nothing abnormal detected

Beginning:  210 g (male) ;  170 g (female)

Day 7:       275 g (male) ;  208 g (female)

Day 14:     300 g (male) ;  219 g (female)

Executive summary:

The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. only

mean bodyweight reported). Groups of 5 male and 5 female rats were gavaged at dose levels of 464, 1000, 2150, 3830, 5000, 6810 and 8250 g/kg bw. The post-exposure observation period was 14 days. Clinical signs like tremor, apathy, unsteady respiration were observed 1 h until day 1 after administration. No death occurred at concentrations up to 3850 mg/kg. The LD50 value is 5783 mg/kg. Therefore, the testsubstance is considerd to be relatively harmless after oral administration.

Conclusion

No death occurred at concentrations up to 3850 mg/kg. The LD50 value is > 5000 mg/kg. Therefore the test substance is considerd to be relatively harmless after oral administration.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 783 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
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: Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions (partly limited documentation; post exposure observation period 7 days; low number of rats)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
Annex of the Guideline
Deviations:
no
GLP compliance:
no
Test type:
other: Inhalation Hazard Test
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 534 g (group 1, mean male), 440 g (group 1, mean female), 490 g (group 2; mean male), 485 g (group 2; mean female)
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Rats exposed for 8 h to a vapour saturated atmosphere at 20 °C. 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.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
vapour saturated atmosphere at 20 °C (vapor pressure < 1mbar at 20 °C)
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: weighing at beginning and at temination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LC0
Exp. duration:
8 h
Remarks on result:
other: saturated vapor
Mortality:
no mortality occurred
Clinical signs:
other: attempts to escape bloody discharge from eyes and nose
Body weight:
Mean body weight
group 1 male: 584 g (beginning), 679 g (termination)
group 1 female: 440 g (beginning), 534 g (termination)
group 2 male: 490 g (beginning), 607 g (termination)
group 2 female: 485 g (beginning), 594 g (termination)
Gross pathology:
nothing abnormal detected
Executive summary:

Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981).

6 rats per sex were exposed sequentially to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder. No death occurred when animals are exposed to a saturated atmosphere of stearoyl chloride for 8 h. The inhalation of a saturated atmosphere represents no acute hazard.

Conclusion

No death occurred when animals are exposed to a saturated atmosphere of stearoyl chloride for 8 h. The inhalation of a saturated atmosphere represents no acute hazard.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Groups of 5 male and 5 female rats were gavaged at dose levels of 464, 1000, 2150, 3830, 5000, 6810 and 8250 g/kg bw. The post exposure observation period was 14 days. Clinical signs like tremor apathy unsteady respiration were observed 1 h until day 1 after administration. No death occurred at concentrations up to 3850 mg/kg. The LD50 value is 5783 mg/kg. Therefore the test substance is considered to be low toxicity after oral administration. The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. only mean bodyweight reported).

6 rats per sex were exposed sequentially to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder. Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981). No death occurred when animals are exposed to a saturated atmosphere of stearoyl chloride for 8 h. The inhalation of a saturated atmosphere represents no acute hazard.

Justification for classification or non-classification

No classification suggested for acute toxicity as criteria of regulation 1272/2008/EC are not met.