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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:
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 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).