Registration Dossier

Administrative data

Description of key information

Based on test results for analogous substances,Zinc, bis(O,O-diisodecyl phosphorodithioato.kappa.s,.kappa.s’) is not considered to be acutely toxic. 

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:
key study
Study period:
1978
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Protocol that complies with scientifically accepted methods, and is sufficiently detailed.
Qualifier:
according to
Guideline:
other: Section 1500.3 – Federal Hazardous Substance and Article, Administration and Enforcement Regulation, Federal Register, Vol. 38, No. 187, p. 27014, 27 September 1973, Section (c) (2) (i).
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
Source: No data available.
Age at study initiation: No data available.
Weight at study initiation: average weight between 200~300 g.
Fasting period before study: Feed was withheld overnight prior to dosing.
Housing: No data available.
Diet: ad libitum
Water: ad libitum
Acclimation period: No data available.

ENVIRONMENTAL CONDITIONS
Temperature (°C): No data available.
Humidity (%):No data available.
Air changes: No data available.
Photoperiod: No data available.

IN-LIFE DATES: From 06/06/1978 To 6/20/1978.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1,000, 2,000, 4,000, 8,000, and 16,000 mg/kg bw
No. of animals per sex per dose:
5/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available.
- Necropsy of survivors performed: gross necropsies were performed.
Preliminary study:
not applicable
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 3 200 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 000 - <= 5 300
Mortality:
1000 mg/kg/bw:
Number of animals= 5; number of deaths: 0

2000 mg/kg/bw:
Number of animals= 5; number of deaths 2

4000 mg/kg/bw:
Number of animals = 5; number of deaths 2

8,000 mg/kg/bw:
Number of animals = 5; number of deaths 5

16,000 mg/kg/bw:
Number of animals = 5; number of deaths 5

Clinical signs:
All animals died in the high dose group.
In the low dose group, all animals appeared ruffled up to 24 h after treatment, but appeared normal thereafter.
In the low dose group, 1/5 female died on day 6; 2/5 females exhibited diarrhea, and 1/5 exhibited diarrhea and a hunched back.
Body weight:
All animals showed bodyweight gain.
Gross pathology:
No gross abnormalities were noted in all animals (either found dead during the study or in the animals necropsied at the conclusion of the study).

Table 1. Results

Dose

(mg/kg)

Body weight

Mortality

(dead/total No.)

Observation

Initial

Final

1,000

260

290

0/5

2 h: lethargic and depressed

24 h: normal

2,000

250

270

2/5

 

30’: depressed

1 h: quite lethargic

3~4 h: semi-comatose

12~18 h: death occurred.

7 d: normal.

4,000

250

275

2/5

8,000

260

-

5/5

3 h: comatose

< 12 h: death occurred.

16, 000

250

-

5/5

Gross pathologic examination revealed nothing remarkable.

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The test article, when administered as received to male Sherman-Wistar rats, had an acute oral LD50 of 3,200 mg/kg bodyweight with 95% confidence limit of from 2,000 to 5,300 mg/kg bodyweight.
Executive summary:

A single dose of the undiluted test material was administered intragastrically to 5 groups of fasted male albino rats (Sherman-Wistar strain) at each treatment level (1,000, 2,000, 4,000, 8,000, and 16,000 mg/kg bw). The animals were observed for signs of toxicity or behavioral changes during the 14 day observation period. Individual weights were recorded on the day of dosing and at termination. All animals died in the 8,000 mg/kg (~ 48 h after treatment) and 16,000 mg/kg (~ 24 h after treatment) dose groups. No mortality in the remaining groups.Gross autopsies were performed and nothing remarkable was revealed.

The oral LD50 value of test material in rats has been determined to be 3,200 mg/kg bodyweight with 95% confidence limit of from 2,000 to 5,300 mg/kg bodyweight.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline, non-GLP study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 232-296 g
- Fasting period before study:
- Housing: Housed individually in wire bottom cages
- Diet (e.g. ad libitum): ad libitum except overnight prior to dosing
- Water (e.g. ad libitum): ad libitum except overnight prior to dosing
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2200 mg/kg, 3300 mg/kg, 5000 mg/kg, 7500 mg/kg
No. of animals per sex per dose:
10 male
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology including: thymus, heart, lungs, liver, kidneys, adrenal glands, spleen, gonads, gastro-intestinal tract, lymph nodes, pancreas, salivary glands, bladder, body fat, skeletal muscle, teeth, eyes and skin.
Statistics:
Berkson, J. Biometrika, 44:411-435, 1957
Sex:
male
Dose descriptor:
LD50
Effect level:
3 100 mg/kg bw
95% CL:
1 800 - 5 100
Mortality:
7500 mg/kg: 10/10 rats died 1-2 days after exposure
5000 mg/kg: 9/10 rats died between 1-9 days after exposure
3300 mg/kg: 6/10 rats died 1-2 days after exposure
2200 mg/kg: 2/10 rats died between 1-8 days after exposure
Clinical signs:
Depresson, diarrhea, reduced food intake
Gross pathology:
Survivors had less than normal amounts of body fat. No other changes observed.
Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline, non-GLP study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH

A read-across analogue approach can be performed for this endpoint because the source substance (CAS 4259-15-8) is structurally similar to the target substance. Both substances consist of substituted phosphorodithioic acid structures complexed with zinc, with differing alkyl chain lengths. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)

Source substance: Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS: 4259-15-8)
Target substance: Zinc, bis(O,O-diisodecyl phosphorodithioato.kappa.s,.kappa.s’) (CAS: 25103-54-2)
For full information on purity and impurities please see the attached read-across justification report.

3. ANALOGUE APPROACH JUSTIFICATION

Source and target substances are structurally similar, differing only due to the length of the alkyl chains and degree of branching. Physico-chemical properties of the source and target substances follow a predictable pattern based on molecular size. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems. For a full justification of the read across approach please see attached read across justification report.

4. DATA MATRIX

See attached read across justification.

Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 232-296 g
- Fasting period before study:
- Housing: Housed individually in wire bottom cages
- Diet (e.g. ad libitum): ad libitum except overnight prior to dosing
- Water (e.g. ad libitum): ad libitum except overnight prior to dosing
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2200 mg/kg, 3300 mg/kg, 5000 mg/kg, 7500 mg/kg
No. of animals per sex per dose:
10 male
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology including: thymus, heart, lungs, liver, kidneys, adrenal glands, spleen, gonads, gastro-intestinal tract, lymph nodes, pancreas, salivary glands, bladder, body fat, skeletal muscle, teeth, eyes and skin.
Statistics:
Berkson, J. Biometrika, 44:411-435, 1957
Sex:
male
Dose descriptor:
LD50
Effect level:
3 100 mg/kg bw
95% CL:
1 800 - 5 100
Mortality:
7500 mg/kg: 10/10 rats died 1-2 days after exposure
5000 mg/kg: 9/10 rats died between 1-9 days after exposure
3300 mg/kg: 6/10 rats died 1-2 days after exposure
2200 mg/kg: 2/10 rats died between 1-8 days after exposure
Clinical signs:
Depresson, diarrhea, reduced food intake
Gross pathology:
Survivors had less than normal amounts of body fat. No other changes observed.
Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Protocol that complies with scientifically accepted methods, and is sufficiently detailed.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH

A read-across analogue approach can be performed for this endpoint because the source substance (CAS 28629-66-5) is structurally similar to the target substance. Both substances consist of substituted phosphorodithioic acid structures complexed with zinc, with differing alkyl chain lengths. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)

Source substance: Zinc bis(O,O-diisooctyl) bis(dithiophosphate) (CAS: 28629-66-5)
Target substance: Zinc, bis(O,O-diisodecyl phosphorodithioato.kappa.s,.kappa.s’) (CAS: 25103-54-2)
For full information on purity and impurities please see read-across justification report.

3. ANALOGUE APPROACH JUSTIFICATION

Source and target substances are structurally similar, differing only due to the length of the alkyl chains and degree of branching. Physico-chemical properties of the source and target substances follow a predictable pattern based on molecular size. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems. For a full justification of the read across approach please see attached read across justification report.

4. DATA MATRIX

See attached read across justification.

Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: Section 1500.3 – Federal Hazardous Substance and Article, Administration and Enforcement Regulation, Federal Register, Vol. 38, No. 187, p. 27014, 27 September 1973, Section (c) (2) (i).
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
Source: No data available.
Age at study initiation: No data available.
Weight at study initiation: average weight between 200~300 g.
Fasting period before study: Feed was withheld overnight prior to dosing.
Housing: No data available.
Diet: ad libitum
Water: ad libitum
Acclimation period: No data available.

ENVIRONMENTAL CONDITIONS
Temperature (°C): No data available.
Humidity (%):No data available.
Air changes: No data available.
Photoperiod: No data available.

IN-LIFE DATES: From 06/06/1978 To 6/20/1978.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1,000, 2,000, 4,000, 8,000, and 16,000 mg/kg bw
No. of animals per sex per dose:
5/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available.
- Necropsy of survivors performed: gross necropsies were performed.
Preliminary study:
not applicable
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 3 200 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 000 - <= 5 300
Mortality:
1000 mg/kg/bw:
Number of animals= 5; number of deaths: 0

2000 mg/kg/bw:
Number of animals= 5; number of deaths 2

4000 mg/kg/bw:
Number of animals = 5; number of deaths 2

8,000 mg/kg/bw:
Number of animals = 5; number of deaths 5

16,000 mg/kg/bw:
Number of animals = 5; number of deaths 5

Clinical signs:
All animals died in the high dose group.
In the low dose group, all animals appeared ruffled up to 24 h after treatment, but appeared normal thereafter.
In the low dose group, 1/5 female died on day 6; 2/5 females exhibited diarrhea, and 1/5 exhibited diarrhea and a hunched back.
Body weight:
All animals showed bodyweight gain.
Gross pathology:
No gross abnormalities were noted in all animals (either found dead during the study or in the animals necropsied at the conclusion of the study).

Table 1. Results

Dose

(mg/kg)

Body weight

Mortality

(dead/total No.)

Observation

Initial

Final

1,000

260

290

0/5

2 h: lethargic and depressed

24 h: normal

2,000

250

270

2/5

 

30’: depressed

1 h: quite lethargic

3~4 h: semi-comatose

12~18 h: death occurred.

7 d: normal.

4,000

250

275

2/5

8,000

260

-

5/5

3 h: comatose

< 12 h: death occurred.

16, 000

250

-

5/5

Gross pathologic examination revealed nothing remarkable.

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The test article, when administered as received to male Sherman-Wistar rats, had an acute oral LD50 of 3,200 mg/kg bodyweight with 95% confidence limit of from 2,000 to 5,300 mg/kg bodyweight.
Executive summary:

A single dose of the undiluted test material was administered intragastrically to 5 groups of fasted male albino rats (Sherman-Wistar strain) at each treatment level (1,000, 2,000, 4,000, 8,000, and 16,000 mg/kg bw). The animals were observed for signs of toxicity or behavioral changes during the 14 day observation period. Individual weights were recorded on the day of dosing and at termination. All animals died in the 8,000 mg/kg (~ 48 h after treatment) and 16,000 mg/kg (~ 24 h after treatment) dose groups. No mortality in the remaining groups.Gross autopsies were performed and nothing remarkable was revealed.

The oral LD50 value of test material in rats has been determined to be 3,200 mg/kg bodyweight with 95% confidence limit of from 2,000 to 5,300 mg/kg bodyweight.

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 100 mg/kg bw

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline, non-GLP study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 2.25-2.75 kg
- Fasting period before study:
- Housing: Housed individually in wire bottom cages
- Diet (e.g. ad libitum): approximately 4 ounces daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: 100%
- Type of wrap if used: plastic sheet


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: test material removed 24 hours after exposure


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg bw
- Concentration (if solution):
- Constant volume or concentration used:
- For solids, paste formed:


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
6
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology including: thymus, heart, lungs, liver, kidneys, adrenal glands, spleen, gonads, gastro-intestinal tract, lymph nodes, pancreas, salivary glands, bladder, body fat, skeletal muscle, teeth, eyes and skin.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
One animal with abraded skin died 13 days after dosing
Clinical signs:
Severe erythema and edema noted at 24 hours. By seven days treated sites were thick and escharotic.
Body weight:
Treated animals weighed significantly less than controls.
Average body weight during study
Control: 2.47 kg (start), 2.49 kg (day 7), 2.85 kg (day 14
Treated: 2.44 kg (start), 2.15 kg (day 7), 2.15 kg (day 14)
Note: Values are an average of 6 rabbits except for day 14 treated, which is the mean of 5 animals
Gross pathology:
Liver-like or necrotic-appearing areas of lung tissue observed in five rabbits. Further histology of the lungs revealed confluent bronchipnuemonia or chronic interstitial pneumonia. Two rabbits had small white liver abcesses that were determined to be of parasitic origin after histological examination.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline, non-GLP study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH

A read-across analogue approach can be performed for this endpoint because the source substance (CAS 4259-15-8) is structurally similar to the target substance. Both substances consist of substituted phosphorodithioic acid structures complexed with zinc, with differing alkyl chain lengths. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)

Source substance: Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS: 4259-15-8)
Target substance: Zinc, bis(O,O-diisodecyl phosphorodithioato.kappa.s,.kappa.s’) (CAS: 25103-54-2)
For full information on purity and impurities please see the attached read-across justification report.

3. ANALOGUE APPROACH JUSTIFICATION

Source and target substances are structurally similar, differing only due to the length of the alkyl chains and degree of branching. Physico-chemical properties of the source and target substances follow a predictable pattern based on molecular size. Based on the similarity of structure, both substances are expected to have similar toxicity, or lack of toxicity, in mammalian systems. For a full justification of the read across approach please see attached read across justification report.

4. DATA MATRIX

See attached read across justification.


Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 2.25-2.75 kg
- Fasting period before study:
- Housing: Housed individually in wire bottom cages
- Diet (e.g. ad libitum): approximately 4 ounces daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: 100%
- Type of wrap if used: plastic sheet


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: test material removed 24 hours after exposure


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg bw
- Concentration (if solution):
- Constant volume or concentration used:
- For solids, paste formed:


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
6
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology including: thymus, heart, lungs, liver, kidneys, adrenal glands, spleen, gonads, gastro-intestinal tract, lymph nodes, pancreas, salivary glands, bladder, body fat, skeletal muscle, teeth, eyes and skin.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
One animal with abraded skin died 13 days after dosing
Clinical signs:
Severe erythema and edema noted at 24 hours. By seven days treated sites were thick and escharotic.
Body weight:
Treated animals weighed significantly less than controls.
Average body weight during study
Control: 2.47 kg (start), 2.49 kg (day 7), 2.85 kg (day 14
Treated: 2.44 kg (start), 2.15 kg (day 7), 2.15 kg (day 14)
Note: Values are an average of 6 rabbits except for day 14 treated, which is the mean of 5 animals
Gross pathology:
Liver-like or necrotic-appearing areas of lung tissue observed in five rabbits. Further histology of the lungs revealed confluent bronchipnuemonia or chronic interstitial pneumonia. Two rabbits had small white liver abcesses that were determined to be of parasitic origin after histological examination.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Acute Oral Toxicity:

For acute oral toxicity, results are read across from two analogous ZDDP substances, CAS 4259 -15 -8 and CAS 28629 -66 -5. For full details of the read across approach, please see the attached read across justification. The results of the key studies for the two read across substances are summarised below. The lowest value from studies with the source substance is used to assess the target substance.

CAS 28629 -66 -5

The oral LD50 was determined to be 3200 mg/kg in male rats (Gabriel, K.L., 1978). Sublethal effects of depression, lethargy, and semi-comatose to comatose states were observed. Survivors appeared normal after 7 days. Necropsy observations were unremarkable, no specific organ toxicity was evident. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification is not required for acute oral toxicity based on the available data.

CAS 4259 -15 -8

This substance does not show any evidence of toxicity via the oral route of exposure in animals when tested in accordance with OECD Guideline 401 (Bullock et al. 1975). The rat oral LD50 is 3100 mg/kg in male rats. Sublethal effects of depression, diarrhea, and reduced food intake were observed. Necropsy observations included reduction of body fat, no specific organ toxicity is evident. 

Acute Dermal Toxicity :

For acute dermal toxicity, results are read across from one analogous ZDDP substance, CAS 4259 -15 -8. For full details of the read across approach, please see the attached read across justification. A summary of the key study available for this substance is presented below.

CAS 4259 -15 -8

This substance does not show any evidence of toxicity via the dermal route of exposure in animals when tested in accordance with OECD Guideline 402 (Bullock et al. 1975). The rat dermal LD50 is greater than 5000 mg/kg in male rabbits. Severe erythema and edema noted at 24 hours. Necrotic-appearing areas of lung tissue observed in five rabbits. Further histology of the lungs revealed confluent bronchopneumonia or chronic interstitial pneumonia.

Justification for classification or non-classification

In accordance with EU CLP (Regulation (EC) No. 1272/2008), classification of this substance is not required for acute toxicity.