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Administrative data

Description of key information

Acute toxicity data indicate a low toxicity: in rats the oral LD50 was 2150-3830 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:
other: Acceptable, well documented study report which meets basic scientific principles.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior treatment and thereafter, day 3, day 7 and day 13 post-treatment. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH.
- Weight at study initiation: males: 179 - 237 g. females: 180 - 201 g.
- Fasting period before study: animals were given no feed about 16 hours before administration, but water was available ad libitum.
- Housing: Stainless steel wire mesh cages, type DK-III (Becker & Co). 5 animals per cage.
- Diet: ad libitum; Kliba-lobordiaet 343 (Klingentalmuehle AG, Switzerland).
- Water: ad libitum
- Acclimation period: at least 1 week
- Animal identification: identification of groups using cage cards

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 (animal room fully air-conditioned).
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12h/12h (6:00 - 18:00 hours / 18:00 - 6:00 hours)
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 6.81, 21.50, 38.30 and 50.00 % (w/v)
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium.
Doses:
681, 2150, 3830, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (dyspnea, apathy, staggering, piloerection, salivation, general state), body weight, gross pathological examination.
Statistics:
no data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 150 - 3 830 mg/kg bw
Based on:
test mat.
Mortality:
681 and 2150 mg/kg bw dosing groups: no deaths occurred
3830 mg/kg bw group: 4/5 females and 5/5 males died on Day 1 after exposure
5000 mg/kg bw group: 5/5 females and 5/5 males died on Day 1 after exposure
Clinical signs:
Dyspnea, apathy, staggering, piloerection, salivation, poor general state were observed in animals from dose groups 2150 mg/kg bw, and higher
Body weight:
Normal body weight gain
Gross pathology:
Animals that died during the test (males and females):
- general congestion
- severe redness of forestomach, glandular stomach and small intestines
- pink colouration of the urine (at 5000 mg/kg bw)

Sacrificed animals (males + females):
- no abnormalities detected in the organs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 150 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral toxicity

In an acute oral toxicity study comparable to OECD guideline 401, Wistar rats (5/sex/dose) were exposed to a single oral dose of 681 - 5000 mg/kg bw 1,1'-(methylimino)dipropan-2-ol by gavage and observed for 14 days (BASF AG, 1987). Clinical findings included dyspnoea, apathy, staggering, piloerection, salivation, poor general state and were observed in animals from dose groups 2150 mg/kg bw and higher. At pathology, general congestion, severe redness of forestomach, glandular stomach and small intestines and pink colouration of the urine (at 5000 mg/kg bw) was observed in animals that died during the test. Animals sacrificed after the observation period showed no pathological abnormalities. The LD50 was 2150-3830 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only study available; adverse effects were observed beyond the classification limit of 2000 mg/kg bw.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII, further testing on acute toxicity (required in section 8.5) does not need to be conducted as the available information show that the criteria are met for classification as corrosive to the skin (R34, skin corr. cat. 1B). In conclusion, further testing is scientifically unjustified.

Justification for selection of acute toxicity – dermal endpoint
In accordance with column 2 of REACH Annex VIII, further testing on acute toxicity (required in section 8.5) does not need to be conducted as the available information show that the criteria are met for classification as corrosive to the skin (R34, skin corr. cat. 1B). In conclusion, further testing is scientifically unjustified.

Justification for classification or non-classification

Based on the results of the acute oral toxicity study, 1,1'-(methylimino)dipropan-2-ol does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.