Trichloroacetaldehyde

Endpoint summary

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:

other: Somnolence (general depressed activity); Ataxia and Alteration of classical conditioning were observed in treated rats.

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 air

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:

other: 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.