bis(hydrogenated tallow C16-18-alkyl)hydroxylamine

Endpoint summary

Description of key information

The test item did not induce acute toxicity after oral and dermal application at 2000 mg/kg.

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:

1995-05-19 to 1995-07-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

31 July 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited; Animal Production; 4332 Stein / Switzerland
- Age at study initiation: young adult albino rats
- Weight at study initiation: 172 to 223 g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: relative humidity of 55 ± 10 %.
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hour/day light cycle.

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight

Doses:

2000 mg/kg bpody weight

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and symptoms: daily for 14 days; Body weight: immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes

Statistics:

NA

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in this study.

Clinical signs:

other: Piloerection and hunched posture were considered unspecific signs of distress (application) in acute tests. All animals recovered within 2 days after application.

Gross pathology:

At necropsy, 4 of 5 males had a mottled thymus. No other deviations from normal morphology were found.

Other findings:

None

Interpretation of results:

GHS criteria not met

Conclusions:

Upon single oral administration of 2000 mg/kg to male and female rats (Limit test) and a 14 day post-treatment observation period, an LD50 of greater than 2000 mg/kg was determined for the test item.

Executive summary:

In an oral toxicity study according to OECD guideline 401, 5 rats per sex were dosed once with the test article in arachis oil by gastric intubation at a dose level of 2000 mg/kg body weight and observed for 14 days. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortalities were recorded. Piloerection and hunched posture were considered unspecific signs of distress (application) in acute tests. All animals recovered within 2 days after application. Body weight was not affected by the treatment. At necropsy, 4 of 5 males had a mottled thymus. No other deviations from normal morphology were found. The oral LD50 value of the test article in rats was established to exceed 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 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

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-06-06 to 1995-08-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

31 July 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited; Animal Production; 4332 Stein / Switzerland
- Age at study initiation: young adult albino rats
- Weight at study initiation: 201 to 230 g
- Fasting period before study: none
- Housing: individually housed in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: relative humidity of 55 ± 10%
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hour/day light cycle

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 10 % of body surface
- Type of wrap: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with luke warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg
- Concentration: 500 mg/mL
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied: 4 mL/kg bw
- Concentration: 500 mg/mL

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and symptoms: daily for 14 days; Body weight: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes

Statistics:

NA

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in this study.

Clinical signs:

other: No signs of acute dermal toxicity were observed in this study.

Gross pathology:

At necropsy, no deviations from normal morphology were found.

Other findings:

None

Interpretation of results:

GHS criteria not met

Conclusions:

At 2000 mg/kg the test item elicited no signs of acute toxicity in male and female rats.

Executive summary:

In a GLP-compliant acute dermal toxicity study (OECD 402), the test article in oleum arachidis was administered to five male and five female rats by dermal application at 2000 mg/kg body weight for 24 hours. The test article was evenly dispersed on the skin covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. No signs of acute dermal toxicity were observed in this study and animals showed normal body weight gain. At necropsy, no deviations from normal morphology were found. In conclusion, the dermal LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral

In a GLP-compliant acute oral toxicity study (OECD 401), the test substance in arachis oil was administered by oral gavage to five rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred in this study. Piloerection and hunched posture were considered unspecific signs of distress (application) in acute tests. All animals recovered within 2 days after application. Body weight was not affected by the treatment. At necropsy, 4 of 5 males had a mottled thymus. No other deviations from normal morphology were found. Therefore, the oral LD value in male and female rats was established to exceed 2000 mg/kg body weight.

Dermal

In a GLP-compliant acute dermal toxicity study (OECD 402), the test article in oleum arachidis was administered to five male and five female rats by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. No signs of acute dermal toxicity were observed in this study and animals showed normal body weight gain. At necropsy, no deviations from normal morphology were found. In conclusion, the dermal LD50 value in rats was established to exceed 2000 mg/kg body weight.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No 1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No 1272/2008,as amended for the eighth time in Regulation (EU) No 2016/218.