Calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 - 23 December 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross reference'.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

11 - 23 December 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross reference'.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN 41700.92


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item was diluted to achieve the relevant dosing level.
- Final preparation of a solid: Test item was diluted to achieve the relevant dosing level. Before treatment the suspension was homoneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

FORM AS APPLIED IN THE TEST (if different from that of starting material) : suspension

Species:

rat

Strain:

other: Tlf: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: raised on the premises
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: 154 ± 6.8 g (males), 163 ± 10.5 g (females)
- Fasting period before study: animals were fasted overnight prior to administration.
- Diet: rat food (NAFAG, Gossau SG), offered ad libitum
- Housing: animals were housed in groups of 5 in Macrolon III cages
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10 hours lighy cycle day

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2% carboxymethylcellulose + 0.1% Tween 80

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/ kg bw

DOSAGE PREPARATION : Test item was diluted to achieve the relevant dosing level. Before treatment the suspension was homoneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2,3, 5 and 24 hours after treatment, and daily on days 2 to 14
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities observed during the study period.

Clinical signs:

Slight signs of dyspnoea observed from 1 h to 6 days after treatment.
Animals had slight exophthalmos until 5 h after administration. Animals showed slight to moderate ruffled fur until Day 4. Slight to moderate diarrhoea was observed until Day 2 and a slightly curved body position until Day 5. All animals recovered within 7 days.

Body weight:

No effects on body weight.

Gross pathology:

No treatment related effects.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was detemined to be > 5000 mg/kg bw.

Executive summary:

A study for acute oral toxicity of N-methyl-N-(C18-(unsaturated)alkanoyl)glycine was performed in Sprague-Dawley rats according the method similar to OECD guideline 401 (Ciba Geigy, 1981).

A group of 10 rats (5 males and 5 females) was dosed with 5000 mg/kg bw of the test substance by gavage. The observations were conducted for a period of 14 days after the treatment. There were no mortalities during the study period. Observed clinical signs included slight dyspnoea, slight exophthalmos and slight to moderate ruffled fur and slight to moderate diarrhoea and a slightly curved body position. All animals recovered within 7 days. No treatment related effects on body weight were observed and no substance-related findings were revealed during necropsy. The oral LD50 for male and female rats was considered to be greater than 5000 mg/kg bw.

Based on the results of the acute oral toxicity study, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine

EC Number:

203-749-3

EC Name:

(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine

Cas Number:

110-25-8

Molecular formula:

C21H39NO3

IUPAC Name:

N-methyl-N-[C18-(unsaturated)alkanoyl]glycine

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN 41700.92


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item was diluted to achieve the relevant dosing level.
- Final preparation of a solid: Test item was diluted to achieve the relevant dosing level. Before treatment the suspension was homoneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

FORM AS APPLIED IN THE TEST (if different from that of starting material) : suspension

Test animals

Species:

rat

Strain:

other: Tlf: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: raised on the premises
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: 154 ± 6.8 g (males), 163 ± 10.5 g (females)
- Fasting period before study: animals were fasted overnight prior to administration.
- Diet: rat food (NAFAG, Gossau SG), offered ad libitum
- Housing: animals were housed in groups of 5 in Macrolon III cages
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10 hours lighy cycle day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2% carboxymethylcellulose + 0.1% Tween 80

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/ kg bw

DOSAGE PREPARATION : Test item was diluted to achieve the relevant dosing level. Before treatment the suspension was homoneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2,3, 5 and 24 hours after treatment, and daily on days 2 to 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities observed during the study period.

Clinical signs:

Slight signs of dyspnoea observed from 1 h to 6 days after treatment.
Animals had slight exophthalmos until 5 h after administration. Animals showed slight to moderate ruffled fur until Day 4. Slight to moderate diarrhoea was observed until Day 2 and a slightly curved body position until Day 5. All animals recovered within 7 days.

Body weight:

No effects on body weight.

Gross pathology:

No treatment related effects.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was detemined to be > 5000 mg/kg bw.

Executive summary:

A study for acute oral toxicity of N-methyl-N-(C18-(unsaturated)alkanoyl)glycine was performed in Sprague-Dawley rats according the method similar to OECD guideline 401 (Ciba Geigy, 1981).

A group of 10 rats (5 males and 5 females) was dosed with 5000 mg/kg bw of the test substance by gavage. The observations were conducted for a period of 14 days after the treatment. There were no mortalities during the study period. Observed clinical signs included slight dyspnoea, slight exophthalmos and slight to moderate ruffled fur and slight to moderate diarrhoea and a slightly curved body position. All animals recovered within 7 days. No treatment related effects on body weight were observed and no substance-related findings were revealed during necropsy. The oral LD50 for male and female rats was considered to be greater than 5000 mg/kg bw.

Based on the results of the acute oral toxicity study, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008.