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Diss Factsheets

Administrative data

Description of key information

Acute Oral

Acute toxicity: oral. 33Oxy.001

The Oral LD50 of the test substance was determined to be 3160 mg/kg bw in male and female rats. This substance is classified as OECD GHS Toxicity Category V for oral toxicity.

Acute toxicity: oral. MA.002

The Oral LD50 of Maleic acid was determined to be 2870 (2470-3250) mg/kg bw or Oral LD50=2382.1 (2050.1-2697.5) mg/kg bw. This substance is classified as OECD GHS Toxicity Category V for oral toxicity.

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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Not GLP
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
minimum purity 95%
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Weight at study initiation: mean males: 182 g; mean females: 171 g
- Fasting period before study: 16 hours
- Housing: 5 animals per cage (type DK-III, Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet (Klingentalmuehle AG, Kaiseraugst, CH) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- Concentration in vehicle: 14.7%, 21.5%, 31.6%
- Justification for choice of vehicle: aqueous preparation corresponds to physiological medium
Doses:
1470 mg/kg bw, 2150 mg/kg bw, 3160 mg/kg bw at 10mL/kg
No. of animals per sex per dose:
No. of animals per sex per dose: 5 Male and 5 Female animals per dose group.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: check for mortality twice per day on working days and once per day on weekends/public holidays; clinical observation several times on the day application, afterwards at least once per day on working days; weighing on the day of application and on days 2, 7 and 12
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 160 mg/kg bw
Based on:
test mat.
Mortality:
Mortality:
Dose (mg/kg) 3160 2150 1470
Males

Dead animals/total
animals after

1 h 0/5 0/5 0/5
1 d 4/5 0/5 0/5
2 d 4/5 0/5 0/5
7 d 4/5 0/5 0/5
14 d 4/5 0/5 0/5

Females
Dead animals/total
animals after

1 h 0/5 0/5 0/5
1 d 2/5 0/5 0/5
2 d 2/5 0/5 0/5
7 d 2/5 0/5 0/5
14d 2/5 0/5 0/5
Clinical signs:
other: Clinical signs included dyspnoea, rattling breath, apathy, agitation, abnormal position, staggering, tremble, tremor, spastic gait, piloerection, poor general state
Gross pathology:
- Animals that died: general congestive hyperemia; stomach: bloody gastritis in glandular stomach; intestine: atonic, reddened diarrheal content.
- Sacrificed animals: No abnormalities.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The Oral LD50 = 3160 mg/kg bw.
Executive summary:

The Oral LD50 of the test substance was determined to be 3160 mg/kg bw in male and female rats. This substance is classified as OECD GHS Toxicity Category V for oral toxicity.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977-05-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Charles river (CD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
- 0 grams - 222 grams (Mean weight: 202.7 grams) for female animal
- Fasting period before study: 18 to 20 hours
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Rat Chow
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 24
- Humidity (%): 40 to 60
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- Concentration in vehicle: 40%
Doses:
1900 mg/kg bw, 2700 mg/kg bw, 3800 mg/kg bw, 5300 mg/kg bw
No. of animals per sex per dose:
No. of animals per sex per dose: 5 Male and 5 Female animals per dose group.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At 1/4 hr, 1/2 hr, 1 hr, 2 hr and 4 hour timepoints following administration of compound, then daily thereafter for 14 days, Prefasting weights, fasting weights, and daily weights for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, body weight, mortality
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 870 mg/kg bw
Based on:
test mat.
95% CL:
> 2 470 - < 3 250
Mortality:
1900 mg/kg bw (0/5 Male and 2/5 Female),
2700 mg/kg bw (0/5 Male and 3/5 Female),
3800 mg/kg bw (4/5 Male and 5/5 Female),
5300 mg/kg bw (5/5 Male and 5/5 Female).
Clinical signs:
other: Clinical signs observed were: decreased motor activity, coarse body tremors, blanching, salivation, pilo erection, and diarrhoea.
Gross pathology:
Soft stool (In 1 Male animal) / Diarrhea (In 1 Male and 1 Female animal) / Pale kidneys (In 3 Male animals) / liver (In 3 Male animals) / spleen (In 2 Male animals) /, Congested liver (In 2 Male animals) /, Bright/ moderate/deep red lungs (In 5 Male and 12 Female animals), Tan discoloration of lungs (In 1 Female animal), Petechiae on the lungs (In 2 Male and 2 Female animals), Compound/ fluid/ gas filled stomach/ intestine (In 9 Male and 15 Female animals), Nasal/ ocular hemorrhage (In 1 Male and 2 Female animals), Opaque left eye in 1 Male animal.
Other findings:
- Organ weights: None
- Histopathology: None
- Potential target organs: None
- Other observations: None
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The Oral LD50 = 2870 (2470-3250) mg/kg bw or Oral LD50=2382.1 (2050.1-2697.5) mg/kg bw.
Executive summary:

The Oral LD50 of Maleic acid was determined to be 2870 (2470-3250) mg/kg bw or Oral LD50=2382.1 (2050.1-2697.5) mg/kg bw. This substance is classified as OECD GHS Toxicity Category V for oral toxicity.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Justification for type of information:
The read-across prediction was based upon the data available on the source substances. The two source substances Maleic Acid and 3,3'-oxybis(ethyleneoxy)bis(propylamine 4,7,10-Trioxatridecan-1,13-diam are mixed together in water in a 2:1 ratio to form the target substance. The only differences are the charged species and that the target substance only exists in an aqueous solution. The source and target substances are all mono-constituent substances. The molecular weight, number of hydrogen bond donors, number of hydrogen bond acceptors, water solubility, and partition coefficient values for both substances indicate they will have similar bioavailability in both an aquatic environment and after oral dosing.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 470 mg/kg bw

Acute toxicity: via inhalation route

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4,7,10-Trioxatridecan-1,13-diamin
- Physical state/appearance: yellowish liquid
- Purity: min 95%
- Impurities: 4,7-Dioxanonan-9-ol-1-amin
- Expiration date of the lot/batch: July 1985
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Weight at study initiation: mean males: 259 g; mean females: 218 g
- Housing: single housing (type DK-III, Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet (Klingentalmuehle AG, Kaiseraugst, CH) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: ca. 50 cm² of shaved dorsal/dorsolateral skin
- Type of wrap if used: semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2.15 mL/kg
- Concentration: undiluted
Duration of exposure:
24 hours
Doses:
2150 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: check for mortality/moribund animals twice per day on working days and once per day on weekends/public holidays; clinical observation several times on the day application, afterwards at least once per day on working days; weighing on the day of application and on days 2, 6 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: assessment of local effects (30 - 60 min after removal of semiocclusive coverage and afterwards at least once per week)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 150 mg/kg bw
Based on:
test mat.
Mortality:
One male animal died 2 days after application of the test substance.
Clinical signs:
other: Clinical signs included dyspnoea, apathy, aggressiveness, staggering, poor general state.
Gross pathology:
Animal that died: lungs: severe edema
Sacrificed animals: no abnormalities in organs observed
Other findings:
Local skin effects: 1 male animal moderate, 1 male animal superficial erosions with crust formation; other animals: profound necrosis.

Mortality:

Dose (mg/kg)

2150

Males

Dead animals/total animals after

1 h

0/5

1 d

0/5

2 d

1/5

7 d

1/5

14 d

1/5

Females

Dead animals/total animals after

1 h

0/5

1 d

0/5

2 d

0/5

7 d

0/5

14 d

0/5

 

Mean body weights (g):

 

Dose

(mg/kg)

Weight day

0

2

6

13

Males

2150

259

241

263

292

Females

2150

218

241

211

231

 

Symptoms (cageside observations):

Dose (mg/kg)

2150

Males

Dyspnoea

2D-5D

Apathy

2D-5D

Agressiveness

8D-9D

Staggering

2D-5D

Poor general state

2D-5D

Females

Dyspnoea

2D-6D

Apathy

2D-5D

Agressiveness

6D-9D

Staggering

2D-6D

Poor general state

2D-6D

D: Day

 

Local effects

Dose (mg/kg)

2150

Males

Profound necrosis

1D-14D

Edema

1D-14D

Females

Profound necrosis

1D-14D

Edema

1D-14D

D: Day

Interpretation of results:
other: slightly toxic
Remarks:
Migrated information
Conclusions:
Under the conditions of the study, the LD50 for acute dermal toxicity in the rat has been determined to be 2150 mg/kg/bw.
Executive summary:

Under the conditions of the study, the LD50 for acute dermal toxicity in the rat has been determined to be 2150 mg/kg/bw.

Endpoint:
acute toxicity: dermal
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:
Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
The Test Substance was applied to the clipped intact trunk skin of four male New Zealand White rabbits per dose group and were retained in contact with the skin for 24 hours by an impervious plastic film. A 14-day observation period followed removal of the film.
GLP compliance:
no
Test type:
standard acute method
Specific details on test material used for the study:
No data
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Type of coverage:
occlusive
Duration of exposure:
24 hours
Doses:
No data
No. of animals per sex per dose:
4 males
Control animals:
not specified
Details on study design:
Penetration of rabbit skin was estimated by a technique closely akin to the one-day cuff method of Draize and associates, using groups of four male albino New Zealand rabbits weighing 2.5 - 3.5 kg. The fur was removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. The animals were immobilized during the 24-hour contact period, after which the film is removed, and the rabbits are caged for the subsequent 14-day observation period. The LD50 is estimated by the method of Thompson using the tables of Weil.
Sex:
male
Dose descriptor:
LD50
Effect level:
2 525 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 151 - <= 5 535
Remarks on result:
other: calculated from original value 2.50 mL/kg bw using the density of 1.01 g/cm³
Mortality:
No data
Clinical signs:
other: No data
Gross pathology:
No data
Interpretation of results:
other: slightly toxic
Remarks:
Migrated information
Conclusions:
Under the conditions of the study, the LD50 for acute dermal toxicity in New Zealand White (rabbit) has been determined to be 2525 mg/kg/bw.
Executive summary:

Under the conditions of the study, the LD50 for acute dermal toxicity in New Zealand White (rabbit) has been determined to be 2525 mg/kg/bw.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
no data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Data from handbook or collection of data, read-across from maleic anhydride.
Justification for type of information:
Maleic anhydride hydrolyses under test conditions. As a result, it is believed that maleic acid and its salts were the test materials investigated in this study.
Qualifier:
no guideline followed
Guideline:
other: No data
Principles of method if other than guideline:
Test substance was applied as a 40% suspension in corn oil or a 40% aqueous solution with an exposure time of 24 hours and a 14 day exposure observation period. One animal per dose.
GLP compliance:
no
Test type:
other: No data
Specific details on test material used for the study:
- Constituent
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
not specified
Vehicle:
other: corn oil or water
Details on dermal exposure:
Test substance was applied as a 40% suspension in corn oil or a 40% aqueous solution.
Duration of exposure:
24 hours
Doses:
Suspension in corn oil: 631, 1000, 1580, and 2510 mg/kg
Aqueous solution: 251, 398, 631 and 1000 mg/kg
No. of animals per sex per dose:
1 (sex unknown)
Control animals:
not specified
Details on study design:
Observation period: 14 days
Statistics:
No data
Sex:
not specified
Dose descriptor:
LD100
Effect level:
1 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: test substance administered as 40 % suspension in corn oil
Sex:
not specified
Dose descriptor:
LD0
Effect level:
631 mg/kg bw
Based on:
test mat.
Remarks on result:
other: test substance administered as 40 % suspension in corn oil
Sex:
not specified
Dose descriptor:
LD100
Effect level:
631 mg/kg bw
Based on:
test mat.
Remarks on result:
other: test substance administered as 40 % aqueous solution
Sex:
not specified
Dose descriptor:
LD0
Effect level:
398 mg/kg bw
Based on:
test mat.
Remarks on result:
other: test substance administered as 40 % aqueous solution
Mortality:
In the corn oil group, the rabbits survived at 631 mg/kg, but died within 1 day at 1000, 1580, and 2510 mg/kg.
In the aqueous group, the animals survived at 251 and 398 mg/kg, but died within 16 hours at 631 and 1000 mg/kg.
Clinical signs:
other: Effects of both treatments produced reduced appetite and activity, increasing weakness, collapse and death.
Gross pathology:
No data
Interpretation of results:
study cannot be used for classification
Remarks:
Harmful; Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, according to the mortalities observed, the LD50 is higher than 398 mg/kg body weight and lower than or equal to 631 mg/kg body weight.
Executive summary:

Maleic anhydride was administered at various dosed to groups of one rabbit each at doses between 251 and 2510 mg/kg body weight. The test substance was either suspended in corn oil (40 %) or dissolved in water (40 %). Maleic anhydride hydrolyses under test conditions. As a result it is believed that maleic acid and its sodium salt were the test materials investigated in this study.

In the corn oil group, the rabbit survived at 631 mg/kg, but died within 1 day at 1000, 1580, and 2510 mg/kg. In the aqueous group, the animals survived at 251 and 398 mg/kg, but died within 16 hours at 631 and 1000 mg/kg. Effects of both treatments produced reduced appetite and activity, increasing weakness, collapse and death. Gross pathological findings included lung and liver hyperemia, enlarged gallbladder, discoloration of the spleen and kidney, and gastrointestinal inflammation. In survivors, the viscera appeared normal.

The LD50, acute dermal rabbit is therefore estimated to be between 398 (practically: 400) and 1000 mg/kg body weight.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Maleic anhydride hydrolyses under test conditions. As a result, it is believed that maleic acid and its salts were the test materials investigated in this study.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
other: Not stated
Specific details on test material used for the study:
- Constituent
- Maleic anhydride hydrolyses under test conditions. As a result it is believed that maleic acid and its sodium salt were the test materials investigated in this study.
Species:
rabbit
Strain:
other: New Zealand
Sex:
female
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
Three female New Zealand albino rabbits were used per dose and the doses were kept in place by gauze patches under a latex rubber film.
Duration of exposure:
No data
Doses:
No data
No. of animals per sex per dose:
Three
Control animals:
not specified
Details on study design:
No data
Statistics:
No data
Sex:
female
Dose descriptor:
LD50
Effect level:
2 620 mg/kg bw
Based on:
test mat.
Mortality:
No data
Clinical signs:
other: No data
Gross pathology:
No data
Other findings:
No data
Interpretation of results:
other: Relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance was relatively harmless when applied ermally to rabbits. The LD50 was >2000 mg per kg body weight.
Executive summary:

Maleic anhydride was administered to the skin of female rabitts. Three animals were used per dose. Occlusive dressings were used.

The LD50 was 2620 mg per kg body weight. As maleic anhydride hydrolyses under test conditions, it is believed that maleic acid and its sodium salt were the test materials investigated in this study.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Data from handbook or collection of data, read-across from maleic anhydride.
Justification for type of information:
Maleic anhydride hydrolyses under test conditions. As a result, it is believed that maleic acid and its salts were the test materials investigated in this study.
Guideline:
other: No data
Deviations:
not applicable
GLP compliance:
no
Test type:
other: No data
Specific details on test material used for the study:
- Constituent
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data
Duration of exposure:
No data
Doses:
No data
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
No data
Statistics:
No data
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 560 mg/kg bw
Mortality:
No data
Clinical signs:
other: No data
Gross pathology:
No data
Other findings:
No data
Interpretation of results:
other: Harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 derived from an acute dermal toxicity study with rabbits was 1560 mg/kg body weight.
Executive summary:

The LD50 derived from an acute dermal toxicity study with rabbits was 1560 mg/kg body weight.

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Justification for type of information:
The read-across prediction was based upon the data available on the source substances. The two source substances Maleic Acid and 3,3'-oxybis(ethyleneoxy)bis(propylamine 4,7,10-Trioxatridecan-1,13-diam are mixed together in water in a 2:1 ratio to form the target substance. The only differences are the charged species and that the target substance only exists in an aqueous solution. The source and target substances are all mono-constituent substances. The remaining source substance, Maleic Anhydride was used because this is the substance that can be found in the disseminated ECHA dossier for Maleic Acid, and that Maleic Anhydride hydrolyses under test conditions. As a result, it is believed that Maleic Acid and its salts were the test materials investigated in the studies.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 150 mg/kg bw

Additional information

Acute Dermal

Acute toxicity: dermal. Maleic Acid_RA to Maleic Anhydride.001

Maleic anhydride was administered to the skin of female rabitts. 3 animals were used per dose. Occlusive dressings were used.

The LD50 was 2620 mg per kg body weight. As maleic anhydride hydrolyses under test conditions, it is believed that maleic acid and its sodium salt were the test materials investigated in this study.

Acute toxicity: dermal. Maleic Acid_RA to Maleic Anhydride.002

Under the conditions of the study, according to the mortalities observed, the LD50 is higher than 398 mg/kg body weight and lower than or equal to 631 mg/kg body weight.

Acute toxicity: dermal. Maleic Acid_RA to Maleic Anhydride.003

The LD50 derived from an acute dermal toxicity study with rabbits was 1560 mg/kg body weight.

Acute toxicity: dermal. 3,3oxy.002

Under the conditions of the study, the LD50 for acute dermal toxicity in the rat has been determined to be 2150 mg/kg/bw.

Acute toxicity: dermal. 3,3oxy.003

Under the conditions of the study, the LD50 for acute dermal toxicity in New Zealand White (rabbit) has been determined to be 2525 mg/kg/bw.

Justification for classification or non-classification

Read across values from the most suitable substances have been used for classification.

The substance does not meet the criteria for classification for hazardous to the acute toxicity under CLP.