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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

the LD50 is based on a substance that contains 26% acetic acid (LD50 > 2000 mg/kg bw), 20.4% acetic anhydride (LD50 630 mg/kg bw). The LD50 as available there needs to be correct for at least these two components.

This is done with a reversed ATE calculation

males:

(100 -67)/243=26/2000 + 20.4/630 + 20.7/ATE --> this leads to an ATE of 230 mg/kg bw for BR12

females

(100 -67)/154=26/2000 + 20.4/630 + 20.7/ATE --> this leads to an ATE of 122 mg/kg bw for BR12

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
Study period:
1980-1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
non GLP
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Borchen
- Strain: Wistar TNO W4
- Females nulliparous and non-pregnant:no data
- Age at study initiation: males 9 weeks; females 14 weeks
- Weight at study initiation: males: 135-198 g; females: 152-183 g
- Fasting period before study: not mentioned
- Housing: 5/sex/cage in Macrolon type III cages
- Diet: Altromin 1324 (Altromin GmbH, Lage) ad libitum)
- Water: tap water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 1,5 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
males: 0.1, 0.2, 0.25, 0.45 and 0.5 mL/kg bw
females: 0.05, 0.08, 0.1, 0.2, 0.3 and 0.5 mL/kg bw
No. of animals per sex per dose:
10/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several time on day 1 and 2 times daily thereafter (with the exception of weekend days 1 time)
- Body weight: on day 1, 7 and 14:
- Necropsy of survivors performed: yes of all animals
Statistics:
probit analysis
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
0.213 mL/kg bw
Based on:
test mat.
95% CL:
>= 0.164 - <= 0.261
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
243 mg/kg bw
Based on:
test mat.
Remarks on result:
other: calculated based on density
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
0.135 mL/kg bw
Based on:
test mat.
95% CL:
>= 0.1 - <= 0.184
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
154 mg/kg bw
Remarks on result:
other: calculation based on density
Mortality:
males: 0/10, 5/10, 7/10, 9/10 and 10/10 at 0.1, 0.2, 0.25, 0.45 and 0.5 mL/kg bw
females: 0/10, 2/10, 6/10, 6/10, 8/10 and 10/10 at 0.05, 0.08, 0.1, 0.2, 0.3 and 0.5 mL/kg bw
Deaths from 2 hours post dosing onwards
Clinical signs:
general poor condition, sedation and ruffled fur at 0.2 mL/kg and above in males and at 0.08 mL/kg and above in females (ruffled fur at 0.1 and above in females)
Body weight:
severe decrease in body weight at and above 0.2 mL/kg in males and at and above 0.1 mg/kg in females
Gross pathology:
no findings in decedents and survivors
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The LD50 of the substance tested is 154 mg/kg bw
Executive summary:

In an acute oral toxicity tests male and female Wistar rats received the substances at 0.1, 0.2, 0.25, 0.45 and 0.5 mL/kg bw or 0.05, 0.08, 0.1, 0.2, 0.3 and 0.5 mL/kg bw, respectively. Mortality and severe body weight loss were seen in males at 0.2 mL/kg and above and in females at 0.08 -0.1 mL/kg and above. Clinical signs reported included a general poor condition, sedation and ruffled fur. The LD50 in males is 243 mg/kg bw and in females 154 mg/kg bw. The substance needs to be classified as toxic (H301).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
122 mg/kg bw

Additional information

Justification for classification or non-classification

Based on the available information the substance needs to be classified according to Ragulation (EC) No 1272/2008 as H301 (toxic if swallowed).