2,2-dimethylpropane-1,3-diamine

Endpoint summary

Description of key information

LD50 (oral, rat): 1020 mg/kg bw

LD50 (dermal, rat): >1000 < 2000 mg/kg bw

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:

A standardized animal laboratory diet was used.
Fasting period: 15 - 20 h before administration.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test concentrations used were 6.81, 10 and 14.7% (G/V); aqueous solution.
Application volume: 10 ml/kg.

Doses:

681, 1000, and 1470 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:

1 020 mg/kg bw

Mortality:

Male animals: 681 mg/kg: 1/5 after 14 days; 1000 mg/kg: 3/5 after 14 days; 1470 mg/kg: 5/5 after 14 days
Female animals: 681 and 1000 mg/kg: no deaths after 14 days; 1470 mg/kg: 5/5 after 14 days

Clinical signs:

Dyspnea, gasping, apathy, abnormal position, staggering, atony, pain and cornea reflexes missing, spastic gait, urine intense yellow-coloured, ruffled fur, exophthalmos, blood in the nose, breathlessness, poor general state

Body weight:

Mean body weight for male animals: 260 g at study start, 318 g after 13 days
Mean body weight for female animals: 187 g at study start, 253 g after 13 days

Gross pathology:

Animals that died: heart: acute dilatation (right), acute congestive hyperemia; lung: acute flatulence (middle-graded); liver: peripheral lobular pattern; stomach: dilated, atonic, glandular stomach diffusely reddened (severe irritative gastritis); intestine: diffuse reddening of the mucosa, atonic, diarrheic content (enteritis).
Sacrificed animals: nothing abnormal detected.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 acute oral was 1020 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 020 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

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 weights: males 191 g, females 164 g
A standardized animal laboratory diet was offered.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Application area: 25 cm2
Application site: back

Duration of exposure:

24 h

Doses:

1000 and 2000 mg/kg

No. of animals per sex per dose:

3

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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 2 000 mg/kg bw

Mortality:

1000 mg/kg: no deaths after 14 days; 2000 mgkg: all animals died within 48 hours

Clinical signs:

Toxic symptoms: intermittently breathing, apathy, staggering, spastic gait, tonic convulsions, trembling
Local skin findings: after 24 hours necrosis was observed, which was not reversible within 14 days

Gross pathology:

Animals that died: heart: acute dilatation (right), acute congestive hyperemia; kidneys: remarkable pale
Sacrificed animals: nothing abnormal detected

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 dermal for rats was >1000 < 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Additional information

Acute oral toxicity

In an acute oral toxicity study, groups of fasted Sprague-Dawley rats (5/sex) were given a single oral dose of the test substance at doses of 681, 1000 and 1470 mg/kg). Animals were observed for 14 days (BASF AG, 1979). All animals died in the highest dosing group during the first day. 3 male animals died at 1000 mg/kg after 2 days. At the lowest dosing group one male died after 2 days.

Clinical signs are dyspnea, gasping, apathy, abnormal position, staggering, atony, pain and cornea reflexes missing, spastic gait, urine intense yellow-coloured, ruffled fur, exophthalmos, blood in the nose, breathlessness, poor general state. Animals that died: heart: acute dilatation (right), acute congestive hyperemia; lung: acute flatulence (middle-graded); liver: peripheral lobular pattern; stomach: dilated, atonic, glandular stomach diffusely reddened (severe irritative gastritis); intestine: diffuse reddening of the mucosa, atonic, diarrheic content (enteritis). Nothing abnormal was detected for the sacrificed animals.

Based on the results of this study an LD50 of 1020 mg/kg was determined.

  

Acute dermal toxicity

In an acute dermal toxicity study, groups of Sprague-Dawley rats (3/sex) were dermally exposed to the unchanged test substance at concentrations of 1000 and 2000 mg/kg bw for 24 hours (BASF AG, 1979). Animals were then observed for 14 days. No mortality was observed at the 1000 mg/kg. All animals at 2000 mg/kg died within 48 hours. Clinical signs were intermittently breathing, apathy, staggering, spastic gait, tonic convulsions, trembling. Local skin findings after 24 hours necrosis were observed, which were not reversible within 14 days. Animals that died: heart: acute dilatation (right), acute congestive hyperemia; kidneys: remarkable pale. Nothing abnormal detected for sacrificed animals. Based on these findings an LD50 of > 1000 < 2000 mg/kg bw was determined.

Justification for classification or non-classification

Based on the results on acute toxicity testing, the test item is classified and labelled as harmful after single ingestion (cat. 4, H302) and harmful after single skin contact (cat. 4, H312) according to Regulation (EC) No 1272/2008 (CLP).