2-piperidinoethanol

Endpoint summary

Description of key information

The oral LD50 in rats was approx. 11000 mg/kg body weight (well-documented non-guideline, non-GLP study)

 

The dermal LD50 in rats was > 1000 < 2000 mg/kg body weight (well-documented non-guideline, non-GLP study)

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were offered a standardized animal laboratory diet.
Fasting period: 15 - 20 hours before administration.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Concentration used were 4.64, 10, 14.7, 21.5 and 31.6% (G/V).
Application volume (ml/kg): 10

Doses:

464, 1000, 1470, 2150, 3160 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
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 100 mg/kg bw

Mortality:

Male animals: 464 mg/kg: no deaths after 14 days; 1000 mg/kg: 2/5 after 14 days; 1470, 2150 and 3160 mg/kg: 5/5 after 14 days
Female animals: 464 and 1000 mg/kg: 1/5 after 14 days; 1470, 2150, 3160 mg/kg: 5/5 after 14 days

Clinical signs:

other: Dyspnea, gasping, apathy, abnormal position, staggering, atony, trembling, twitching, spastic gait, fibrous twitching, ruffled fur, exsiccosis, exophthalmos, salivation, chromodacryorrhea, agglutinated snouts, constraint gnawing, poor general state.

Gross pathology:

Animals that died: acute congestive hyperemia; gastro-intestinal tract: hemorrhagic enteritis, atonic, diarrheic bloody content.
Sacrificed animals: stomach: forefront of the forestomach thickened.

Interpretation of results:

Category 4 based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 100 mg/kg bw

Quality of whole database:

K2 (study well documented, meets generally accepted scientific principles, acceptable for assessment)

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weight: males 192 g, females 172 g
The animals were offered a standardized animal laboratory diet.

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

The test concentrations used were 50 and 100% (G/V).
Application site: back of the animals
Application are: about 50 cm2

Duration of exposure:

24 hours

Doses:

at

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, toxic signs, local skin findings

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 2 000 mg/kg bw

Mortality:

400, 464, 681 and 1000 mg/kg: no deaths after 14 days; 2000 mg/kg: 9/10 after 14 days

Clinical signs:

other: Toxic signs: dyspnea, excitation, apathy, staggering, trembling, cry of pain, poor general state, morphine tail, tonic convulsions, salivation, spastic gait. Local irritations: see "other findings"

Gross pathology:

Animals that died: heart: dilatation of the atrium; lung: intensified blood content.
Sacrificed animals: nothing abnormal detected.

Other findings:

Local irritations:
2000 mg/kg – male: after 24 hours severe soft necrosis, severe edema; after 7 days: slight parchment-like necrosis, very slight edema; after 13 days: slight leather-like necrosis, partly questionable sallied; females: all animals died within 24 hours.
1000 mg/kg: after 24 hours: severe soft necrosis; severe edema; after 7 days: severe parchment-like necrosis, partly severe sallied, partly severe leather-like necrosis, very slight edema; after 13 days: severe leather-like necrosis, partly slight, severe sallied.
681 mg/kg: after 24 hours: severe soft necrosis, severe edema; after 7 days; severe necrosis, partly parchment-like, partly leather-like, partly slight sallied, very slight edema, very slight purse-string edema; after 13 days: severe leather-like necrosis, partly slight, severe sallied.
464 mg/kg: after 24 hours: severe soft necrosis, severe edema; after 7 days: severe parchment-like necrosis, partly slight sallied, partly very slight purse-string edema; after 13 days: severe leather-like necrosis, partlyslight sallied.
400 mg/kg: after 24 hours: partly slight soft necrosis, partly slight leather-like, slight edema; after 7 days: slight parchment-like necrosis, partly questionable sallied, very slight dema; after 13 days: slight leather-like necrosis, partly slight sallied.

Interpretation of results:

Category 4 based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

1 000 mg/kg bw

Quality of whole database:

K2 (study well documented, meets generally accepted scientific principles, acceptable for assessment)

Additional information

Acute oral toxicity

In a non-GLP acute oral toxicity study the test substance (diluted in water) was applied per gavage to 5 male and 5 female Sprague-Dawley rats per dose group at doses of up to 3160 mg/kg body weight. Physical condition and rate of deaths were monitored throughout an observation period of 14 days. At the end of the observation period all surviving animals were necropsied.

Mortality started at doses of 1000 mg/kg (males) and 464 mg/kg (females). At 1470 mg/kg body weight all animals were dead at the end of the 2 weeks observation period. Animals that died showed the following gross pathological findings: acute congestive hyperemia, hemorrhagic enteritis and atonic, diarrheic bloody content in the gastro-intestinal tract.

Severe clinical signs were observed starting at doses of 1000 mg/kg (e.g. dyspnea, gasping, apathy, abnormal position, staggering, atony, trembling, twitching, spastic gait, exsiccosis, exophthalmos, poor general state).

The acute oral LD50 of the test substance was determined to be approx. 1100 mg/kg body weight.

Acute dermal toxicity

In a non-GLP acute dermal toxicity study Sprague-Dawley rats (5 males and 5 females per dose group) were dermally exposed to doses of 400, 464, 681, 1000 and 2000 mg/kg body weight of the test item (applied as 50 or 100% solution). The application site (back) was covered by an occlusive dressing during the 24-hour exposure period. The animals were observed for 14 days.

Mortality occurred at 2000 mg/kg. 9/10 animals were dead at the end of the observation period.

Furthermore, dose-dependent local irritating effects were observed starting at the dose of 400 mg/kg bw with slight necrosis. Animals of the highest dose group (2000 mg/kg) showed severe soft necrosis and severe edema developing into leather-like necrosis after 13 days.

Accordingly, the acute dermal LD50 was determined to lie in between 1000 and 2000 mg/kg body weight.

Acute inhalation toxicity

There is no reliable study for acute inhalation toxicity available.

In a study where rats were exposed for 7 hours to an atmosphere enriched with vapours of the test substance (for the enrichment 200 L air per hour were conducted through a 5 cm thick layer of the test substance) no mortality was observed. Due to the method of application of the test substance this study is regarded as unreliable as the result is dependent on the toxicity and the volatility of the test substance and no exact concentration of the test substance in the atmosphere was specified.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance has to be classified for oral and dermal acute toxicity Cat. 4, H302 and H312 under Regulation (EC) No. 1272/2008, as amended for the 13th time in Regulation (EU) 2018/1480.