isostearic acid monoisopropanolamide

Endpoint summary

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:

key study

Study period:

From November 11, 1992 to March 25, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

humidity; not but considered to have affected the outcome or the objectives of the study

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

yes

Remarks:

humidity; not but considered to have affected the outcome or the objectives of the study

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Supplier: Iffa-Credo, B.P. 0109 (69592 L’Arbresle Cedex - France)
Acclimatisation: 5 days minimum
Age at initiation of treatment: adult 5 to 7 weeks old
Body weight range at initiation of treatment: males : 130 to 230g and females: 120 to 180g
Temperature : 19 to 25°C (target range)
Relative humidity : 30 to 70 % R.H. (target range)
Air changes: minimum 8 air changes per hour
Lighting cycle: 12 hours light (artificial)/12 hours dark
Diet: pelleted complete diet, ad libitum and water: filtered (0.2 µm) drinking water, ad libitum

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Method: single oral administration by gastric gavage (using a metal canulla)
Volume administered: 2.18 mg/kg bw

Doses:

2006 mg/kg bw (based on a preliminary study)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days

Preliminary study:

Determination of the dose for the limit test: 2000 mg/kg

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 006 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed.

Clinical signs:

other: There were no changes in behaviour or clinicai signs in any of the treated animals during the observation period.

Gross pathology:

There were no macroscopic findings that could be associated with treatment.

None.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the oral LD50 was determined to be >2006 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, isoC18 MIPA (100% active), according to OECD Guideline 401 and EU Method C.1, in compliance with GLP. Groups of 5 male and 5 female Wistar rats received a single dose of 2006 mg/kg bw by oral gavage (2.18 mL/kg bw). This administration was followed by a 14 d observation period. Examinations for mortality and abnormal clinical signs were performed 15 min after administration, then at 1, 2 and 4 h, and thereafter daily for the 14 d study period. All the animals were weighed the day before treatment, immediately before administration of the test substance (Day 1), then on Days 8 and 15. A necropsy was performed for all the animals after the final in vivo observation on Day 15. No mortality was observed. There were no changes in behaviour or clinical signs in any of the treated animals throughout the study. Body weight changes were within the expected range. There were no macroscopic findings that could be associated with treatment. Under the study conditions, the oral LD50 was determined to be >2006 mg/kg bw (Lheritier, 1993).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 006 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

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

Clinical signs:

other: other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 30, 1999 to April 13, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

other: HanIbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: RCC Ltd Biotechnology & Animal Breeding Division CH-4414 Füllinsdorf / Switzerland
Age when treated: 9 weeks for the males and 12 weeks for the females
Temperature: 22 +/- 3°C and relative humidity: 40-70%
Light period: 12 hour light/dark cycle
Diet: pelleted Standard Kliba 3433, ad libitum and water: community tap water, ad libitum

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

The test substance was placed into a glass beaker on a tared Mettler balance and the vehicle (polyethylene glycol PEG 300) was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test substance in the vehicle was maintained during treatment. The preparation was made shortly before dosing.
Approximately 24 hours before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10% of the total body surface. Only those animals without injury or irritation on the skin were used in the test. On test day 1, the test substance was applied at a dose of 2000 mg/kg bw evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Application volume/kg bw: 4.0 mL. Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed.

Duration of exposure:

24h

Doses:

2000 mg/kg bw (at a concentration of 0.5 g/mL in vehivle and administered at a volume of 4 mL/kg)

No. of animals per sex per dose:

5

Control animals:

no

Statistics:

No statistical analysis was used as no deaths occurred.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs were observed during the observation period.

Gross pathology:

No macroscopic findings were observed at necropsy.

None.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the dermal LD50 was determined to be >2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance, isoC18 MIPA (100% active), according to OECD Guideline 402 and EU Method B.3, in compliance with GLP. Groups of 5 male and 5 female HanIbm: WIST (SPF) rats were exposed to the test substance (in polyethylene glycol) at a concentration of 2000 mg/kg bw via a semi-occlusive dermal application (4 mL/kg bw) for 24 h. This application was followed by a 14 d observation period. The animals were examined for clinical signs four times during Day 1 and once daily during Days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on Day 1 prior to administration and on Days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs were observed throughout the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were noted at necropsy. Under the study conditions, the dermal LD50 was determined to be >2000 mg/kg bw (Ullmann, 1999).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral

A study was conducted to determine the acute oral toxicity of the test substance, isoC18 MIPA (100% active), according to OECD Guideline 401 and EU Method C.1, in compliance with GLP. Groups of 5 male and 5 female Wistar rats received a single dose of 2006 mg/kg bw by oral gavage (2.18 mL/kg bw). This administration was followed by a 14 d observation period. Examinations for mortality and abnormal clinical signs were performed 15 min after administration, then at 1, 2 and 4 h, and thereafter daily for the 14 d study period. All the animals were weighed the day before treatment, immediately before administration of the test substance (Day 1), then on Days 8 and 15. A necropsy was performed for all the animals after the final in vivo observation on Day 15. No mortality was observed. There were no changes in behaviour or clinical signs in any of the treated animals throughout the study. Body weight changes were within the expected range. There were no macroscopic findings that could be associated with treatment. Under the study conditions, the oral LD50 was determined to be >2006 mg/kg bw (Lheritier, 1993).

Dermal

A study was conducted to determine the acute dermal toxicity of the test substance, isoC18MIPA (100% active), according to OECD Guideline 402 and EU Method B.3, in compliance with GLP. Groups of 5 male and 5 female HanIbm: WIST (SPF) rats were exposed to the test substance (in polyethylene glycol) at a concentration of 2000 mg/kg bw via a semi-occlusive dermal application (4 mL/kg bw) for 24 h. This application was followed by a 14 d observation period. The animals were examined for clinical signs four times during Day 1 and once daily during Days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on Day 1 prior to administration and on Days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs were observed throughout the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were noted at necropsy. Under the study conditions, the dermal LD50 was determined to be >2000 mg/kg bw (Ullmann, 1999).

Justification for classification or non-classification

Based on the results of acute toxicity studies in rats, the test substance does not require classification according to CLP (EC 1272/2008) criteria.