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Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats, mouse, rabbis and guinea pigs for the test chemical. The LD50 value is 850 mg/kg bw in rats. The study concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value and range with the criteria of CLP regulation, the given test chemical can be classified in ‘Category 4’ for acute oral toxicity.

Acute Inhalation Toxicity:

The LC50 value is ≤0.5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 1” for acute inhalation toxicity.

Acute Dermal toxicity:

Acute dermal toxicity study was done in guinea pigs using test material.50% mortality observed at dose range 1510-15000 mg/kg, hence, LD50 was considered to be1510-15000 mg/kg body weight. When guinea pigs were treated with test chemical by dermal application.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source.
Qualifier:
equivalent or similar to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
Acute oral toxicity study of the given test chemical was performed in Rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
850 mg/kg
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
not specified
Statistics:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
850 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality observed
Mortality:
50% mortality was observed at 850 mg/kg bw.
Clinical signs:
Somnolence (general depressed activity); Ataxia and Alteration of classical conditioning were observed in treated rats.
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute oral LD50 value was considered to be 850 mg/kg body weight, when rats were treated with the given test chemical orally.
Executive summary:

Acute oral toxicity study was done in rat using test material at dose concentration of 850 mg/kg bw. Animals were observed for mortality and signs of toxicity. 50% mortality observed at dose 850 mg/kg bw. Clinical signs like Somnolence (general depressed activity); Ataxia and Alteration of classical condition were observed. Hence, the acute oral LD50 value was considered to be 850 mg/kg body weight, when rats were treated with the given test chemical orally.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
850 mg/kg bw
Quality of whole database:
Data is from secondary source.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary literature
Qualifier:
equivalent or similar to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
Acute inhalation toxicity study of test chemical in albino rats
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: Specific age was not mention young rats were taken
- Weight at study initiation: 144 grams
- Fasting period before study: No data available
- Housing: in a stock cages
- Diet (e.g. ad libitum): standard laboratory diet (Purina Rat Chow)ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25°C
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
clean air
Remark on MMAD/GSD:
No data available
Details on inhalation exposure:
No data available
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Remarks on duration:
total : 240min
Concentrations:
0.24,0.36,0.38,0.71,6.32 mg/l
No. of animals per sex per dose:
Total :50
0.24mg/l :10
0.36mg/l:10
0.38mg/l:10
0.71mg/l:10
6.32mg/l:10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Weighing: Before and after inhalation
- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs: Yes
body weight: Yes, Before and after 14 days of observation
organ weights: yes
histopathology: No data available
other:
Statistics:
Litchfield and Wilcoxon
Preliminary study:
No data available
Sex:
male
Dose descriptor:
LC50
Effect level:
0.44 mg/L air
Based on:
test mat.
95% CL:
> 0.38 - < 0.5
Exp. duration:
240 min
Remarks on result:
other: mortality was observed
Mortality:
Mortality was observed at dose 0.36 and 0.38 at four to five days of exposure and at dose 0.71 and 6.32 death was observed at one to three days.
Clinical signs:
other: Sneezing was noted approximately one-half hour after the start of the inhalation period. Hypoactivity, ptosis, and dyspnea occurred at about one hour, with gasping and prostration at two to three hours.
Body weight:
At dose 0.24,0.36 and 0.38 body weight was observed as 70, 39 and 58 grams all are within the normal limits
Gross pathology:
Moderate to severe diffuse red discoloration of the lungs were seen. Three rats from Group 2 did not reveal any gross pathologic alteration
Other findings:
No data available

Acute Vapour Inhalation Toxicity study- Albino Rats

                              Mortality Data

Group

Average. Nominal

Vapour Concentration

Number of Animals tested

Observed precent death

Expected percent death

I

0.24

10

0

0.01

II

0.36

10

10

12.10

III

0.38

10

20

20.00

VI

0.71

10

100

99.86

V

6.32

10

100

100

Acute Vapour Inhalation LC50 = 0.44mg,/L air (four-hour exposure)

LimitsofLC50 at the 95 %Levelofconfidence=0.38 – 0.50mg/L air

 

Interpretation of results:
Category 1 based on GHS criteria
Conclusions:
The LC50 value was considered to be 0.44 mg/l of air (vapour) .When rats were inhaled with the given test chemical.
Executive summary:

Acute inhalation toxicity test was conducted in male rats of Sprague-Dawley strain. 5 groups of 10 rats were taken for test. Rats were exposed for 4 hrs and observed for 14 days. Body weight was measured before and after 14 days of observation. Gross pathology was conducted for the animal which died during test and after completion of observation period. At dose 0.24,0.36 and 0.38 body weight was observed as 70, 39 and 58 grams all are within the normal limits. Moderate to severe diffuse red discoloration of the lungs were seen. Mortality was observed at  dose 0.36 and 0.38 at four to five days of exposure and at dose 0.71 and 6.32 death was observed at one to three days. Therefore, the LC50  was considered to be 0.44 mg/l of air (vapour) .When rats were inhaled with the given test chemical.

 

 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
0.44 mg/m³
Quality of whole database:
Data is from secondary source.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary literature
Qualifier:
equivalent or similar to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
Acute dermal toxicity study of 2, 2, 2-trichloroacetaldehyde was performed in guinea pig .
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report):2, 2, 2-trichloroacetaldehyde
- Molecular formula :C2HCI3O
- Molecular weight :147.387 g/mole
- Substance type:organic
- Physical state:Liquid
Purity:No data available
- Impurities (identity and concentrations):No data available
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data available
Duration of exposure:
No data available
Doses:
1510-15000 mg/kg
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 510 - 15 000 mg/kg bw
Based on:
test mat.
Mortality:
No data available
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: No classified
Conclusions:
LD50 was considered in range of 1510-15000 mg/kg body weight, when guinea pigs were treated with the given test chemical by dermal application.
Executive summary:

Acute dermal toxicity study was done in guinea pigs using test material.50% mortality observed at dose range 1510-15000 mg/kg ,hence, LD50 was considered to be1510-15000mg/kg body weight. When guinea pigs were treated with test chemical by dermal application.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
1 510 mg/kg bw
Quality of whole database:
Data is from secondary source.

Additional information

Acute oral toxicity:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats, mouse, rabbits and guinea pigs for test chemical. The studies are summarized as below –

 

Acute oral toxicity study was done in rats, mice, guinea pigs and rabbits using test material at dose concentration of 850, 725, 940 and 1400 mg/kg bw respectively. Animals were observed for mortality and signs of toxicity. 50% mortality observed at dose 850, 725, 940 and 1400 mg/kg bw. Clinical signs like Somnolence (general depressed activity); Ataxia and Alteration of classical condition were observed. Hence, the acute oral LD50 value was considered to be 850, 725, 940 and 1400 mg/kg body weight respectively, when rats, mice, guinea pigs and rabbits were treated with the given test chemical orally.

 

This study is supported with another study mentioned in authoritative database for the given test chemical. The acute oral toxicity study was conducted at dose range of 50-400 mg/kg bw in rats. Animals were observed for mortality. Mortality was observed in between 50 -400 mg/kg bw. Hence, the acute oral toxicity dose, LD50 was considered to be in the range of 50-400 mg/kg body weight, when rats were treated with the given test chemical orally.

 

The above study is supported with the acute oral toxicity study done in rat using test chemical at 600 mg/kg bw. Animals were observed for mortality. 50% mortality observed at dose 600 mg/kg. Hence, the acute oral LD50 value was considered to be 600 mg/kg body weight, when rats were treated with the given test chemical orally

 

All the above studies are further supported with acute oral toxicity study done in rat using test material at 670 mg/kg bw. Animals were observed for mortality. 50% mortality was noted at 670 mg/kg bw. Hence, the acute oral LD50 value was considered to be 670 mg/kg body weight, when rats were treated with the given test chemical orally.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value and range with the criteria of CLP regulation, the given test chemical can be classified in ‘Category 4’ for acute oral toxicity.

 

Acute Inhalation Toxicity:

Acute inhalation toxicity test was conducted in male rats of Sprague-Dawley strain. 5 groups of 10 rats were taken for test. Rats were exposed for 4 hrs and observed for 14 days. Body weight was measured before and after 14 days of observation. Gross pathology was conducted for the animal which died during test and after completion of observation period. At dose 0.24, 0.36 and 0.38 body weight was observed as 70, 39 and 58 grams all are within the normal limits. Moderate to severe diffuse red discoloration of the lungs were seen. Mortality was observed at dose 0.36 and 0.38 at four to five days of exposure and at dose 0.71 and 6.32 death was observed at one to three days. Therefore, the LC50 was considered to be 0.44 mg/l of air (vapour) .When rats were inhaled with the given test chemical.

 

Another acute inhalation toxicity study was performed in rats at 44 mg/l concentration for 2 hrs of exposure. 2 rats were taken for the test. After exposure period 1 rats were died and other having acute pulmonary edema. Therefore, the LC50 value was considered to be 44 mg/litre concentration, when rats treated with test chemical. 

 

From the above key study, the LC50 value is ≤0.5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 1” for acute inhalation toxicity.

Acute Dermal toxicity:

Acute dermal toxicity study was done in guinea pigs using test material.50% mortality observed at dose range 1510-15000 mg/kg, hence, LD50 was considered to be1510-15000 mg/kg body weight. When guinea pigs were treated with test chemical by dermal application.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity; LD50 value is at dose range 1510-15000 mg/kg, for acute dermal toxicity and LC50 value is ≤0.5 mg/L, for acute inhalation toxicity. Thus, comparing these values and ranges with the criteria of CLP regulation, the given test chemical can be classified in ‘Category 4’ for acute oral toxicity, “Category 1” for acute inhalation toxicity and cannot be classified for acute dermal toxicity.