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Administrative data

Description of key information

Oral:

The LD50 in the mouse was 1175 mg/kg bw.

The LD50 in the rat was > 1000 and <=2500 mg/kg bw.

The LD50 in the rabbit was >500 and <= 1000 mg/kg bw.

Dermal:

The LD50 in the rabbit was considered to be greater than 3000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
(only basic information given)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
mouse
Strain:
other: Tylers Original
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 20 ± 2
- Fasting period before study: overnight
- Housing: in solid floor polycarbonate boxes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Photoperiod: natural lighting conditions
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/mL solution
Doses:
500, 1000, 1500, 2000 and 2500 mg/kg bw (and also 5000 mg/kg bw in the preliminary study).
No. of animals per sex per dose:
2 in preliminary study
10 in main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
Preliminary study:
A rangefinding trial was performed with 2 animals per dose (500, 1000, 2500 and 5000 mg/kg bw)
500 and 1000 mg/kg bw: no deaths occured
2500 mg/kg bw and more: all animals died on Day 1
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 175 mg/kg bw
Based on:
test mat.
95% CL:
>= 987 - <= 1 410
Mortality:
For details refer to Table 1 under "any other information on results".
Clinical signs:
500 mg/kg bw and more: convulsions and stretching within 90 min of dosing, symptoms less severe in survivors after 48 h, asymptomatic after 72 h

Table 1 Acute oral toxicity: main study data for Day 14 only

Dose Mortality on Day 14
[mg/kg bw]
  N*
Males/Females
500 0/10
1000 6/10
1500 8/10
2000 9/10
2500 10/10

Table 2 Acute oral toxicity in the mouse: combined preliminary and main study data

 Dose mg/kg bw  Mortality on Day 4 (No.)
 500 0/12
 1000  6/12
 1500  6/12
 2000  8/10
 2500  11/12
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 = 1175 mg/kg bw.
Executive summary:

The LD50 in the mouse was 1175 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
(only basic information given)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
test performed using 2 animals only
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2000 ± 200 g
- Fasting period before study: overnight
- Housing: individually caged

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Photoperiod: natural lighting conditions
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL solution
Doses:
500, 1000, 2500 and 5000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 500 - <= 1 000 mg/kg bw
Based on:
test mat.
Mortality:
500 mg/kg bw: 0/2
1000 mg/kg bw and more: 1/2 (24 h post-dose), 2/2 (at 48 h post-dose)
2500 mg/kg bw and more: 2/2
Clinical signs:
500 mg/kg bw and more: disorientation and stretching within 120 min of dosing, survivors asymptomatic after 48 h
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 >500 and <= 1000 mg/kg bw.
Executive summary:

The LD50 in the rabbit was >500 and <= 1000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
(only basic information given)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
test performed using 2 animals only
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 ± 20 g
- Fasting period before study: overnight
- Housing: in grid-floor cages

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Photoperiod: natural lighting conditions
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL solution
Doses:
500, 1000, 2500 and 5000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 1 000 - < 2 500 mg/kg bw
Based on:
test mat.
Mortality:
500 and 1000 mg/kg bw: 0/2
2500 mg/kg bw and more: 2/2 (24 h post-dose)
Clinical signs:
500 mg/kg bw and more: trembling and convulsions within 120 min of dosing, survivors asymptomatic after 48 h
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 > 1000 and <=2500 mg/kg bw.
Executive summary:

The LD50 in the rat was > 1000 and <=2500 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Acute toxicity data are available for the oral and dermal routes. Examination of the life cycle of the substance indicates that human exposure is controlled by risk management measures in the inductrial and professional settings. It is therefore expected that inhalation exposure from the identified uses will be low. In addition, the most likely route of exposure for workers and consumers is the dermal route, where lack of systemic toxicity has been experimentally demonstrated. Consumers will only be exposed to low concentrations of the substance in solutions, where inhalation exposure is unlikely.
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Reported in 1950
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method was described as essentially like that of Draize et al., (1944) J. Pharmacol. Exp. Therap. 82; 377. Cited in Principles and Methods of Toxicology, 5th Edition; ed. A. Wallace-Hayes, 2008.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Dehydroacetic acid.
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
occlusive
Vehicle:
other: Greaseless base - "Neobase".
Details on dermal exposure:
After application of the dosage, the site was occluded by bandages for 24 hours after which time they
were removed and the site washed with soap and water.
Duration of exposure:
24 hours
Doses:
1000, 3000 or 5000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Sex:
not specified
Dose descriptor:
approximate LD50
Effect level:
> 3 000 - < 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One of the two rabbits treated at 5000 mg/kg bw died
Body weight:
Transitory weight loss
Interpretation of results:
GHS criteria not met
Conclusions:
No rabbits died at 1000 or 3000 mg/kg bw. The LD50 was considered to be greater than 3000 mg/kg bw
Executive summary:

Rabbits were treated dermally for 24 hours with dihydroacetic acid at dosages between 1000 and 5000 mg/kg bw. There were no deaths at 1000 or 3000 mg/kg bw. The LD50 was considered to be greater than 3000 mg/kg bw.

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
refer to analogue justification provided in IUCLID section 13
Reason / purpose:
read-across source
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 000 - < 5 000 mg/kg bw
Based on:
test mat.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 000 mg/kg bw

Additional information

Justification for classification or non-classification

Oral:

The LD50 in the mouse was 1175 mg/kg bw. : GHS Cat. 4

The LD50 in the rat was > 1000 and <=2500 mg/kg bw. : GHS Cat. 4

The LD50 in the rabbit was > 500 and <= 1000 mg/kg bw. : GHS Cat. 4

Dermal:

The LD50 in the rabbit was > 3000 mg/kg bw : GHS not classified