N,N-bis(2-methylpropyl)formamide

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:

1988-04-13 to 1988-04-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well-documented, scientifically acceptable study report; no GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Weight at study initiation: males: 193 g; females: 179 g
- Fasting period before study: Yes, 16 hours before administration.
- Housing: groupwise (5 animals per cage)
- Diet: ad libitum (Kliba Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland)
- Water: ad libitum (tap water)
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 4.64, 10.0, 21.5 g/100 mL (w/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

464, 1000 and 2150 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 working day). A check of moribund or dead animals was made twice each working day and once on public holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 464 - < 1 000 mg/kg bw

Mortality:

No mortality was observed in the lowest dosing group. 4 males and all females died at 1000 mg/kg bw. All animals died in the highest dosing group.

Clinical signs:

other: dyspnea, apathy, abnormal position, staggering, twitching, extention, saltatory and flexion spasms, rolling convulsions, piloerection, exophthalamus (females only), salivation, poor general state

Gross pathology:

Animals that died: general congestion
Sacrificed animals: no pathologic findings noted

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

464 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1988-04-27 to 1988-05-11

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Basic data given. Only orientating information about the inhalation hazard.

Qualifier:

no guideline followed

Principles of method if other than guideline:

BASF-Test (IRT = inhalation risk test):
The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of the test substance at the temperature chosen for vapor generation (50°C). Rats were exposed to the test substance vapors for 8 hours. Documentation of clinical signs was performed over the 7-day study period.

GLP compliance:

no

Test type:

other: Inhalation hazard test

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach, Germany
- Age at study initiation: about 8 - 9 weeks
- Weight at study initiation (mean): males: 262 g, females: 188 g
- Housing: They were housed in groups of three in type D III wire mesh cages supplied by Becker & Co., without bedding.
- Diet: KLIBA 24-343-4 rat/mouse laboratory diet (10 mm pellets, Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland), ad libitum in the exposure-free period.
- Water: ad libitum in the exposure-free period
- Acclimation period: At least 5 days
- Animal identification: colour lines on the base of the tail

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30- 70 %
- Photoperiod: 12 hours dark/ 12 hours light

Route of administration:

other: mixture of the vapour of the test substance and air

Vehicle:

other: unchanged

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus, filled volume: Glass bottle (fritted glass flask, pore-size 90 - 150 um, diameter 30 mm) filled to a height of 5 cm with the test substance
- Source and rate of air: compressed air, 200 L/h
- Treatment of exhaust air: Disposal
- Temperature in air chamber: Between 19 and 25 °C

Duration of exposure:

7 h

Concentrations:

The mean concentration of the test substance (calculated for a study duration of 7 hours) was 0.43 mg/L.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical examinations took place each workday. Lethality was checked each day.
- Necropsy of survivors performed: yes

Mortality:

No mortality was observed.

Clinical signs:

other: During exposure: intermittently breathing, increased masticatory movement, snout wiping After exposure: nothing abnormal detected

Body weight:

Not determined.

Gross pathology:

No treatment related effects were seen during necropsy.

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:

1988-05-10 to 1988-05-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well-documented, scientifically acceptable study report.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH,7950 Biberach, Germany
- Weight at study initiation (mean): males: 261 g, females: 222 g
- Housing: Single housing in stainless steel wire mesh cages, Typ DK-III (Becker & Co., Castrop-Rauxel)
- Diet: Standardized animal laboratory diet, ad libitum (Kliba-Labordiaet 343, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland)
- Water: Tap water ad libitum
- Acclimation period: For at least one week
- Animal identification: Identification of groups using cage cards

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hours dark/ 12 hours light

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal and dorsolateral parts of the trunk (about 50 cm²)
- Type of wrap if used: Covered with a porous dressing (four layers absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the application side with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2.29 mL/kg

Duration of exposure:

24 h

Doses:

2000 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
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of application, 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, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Symptoms and local findings: no abnormalities

Gross pathology:

no pathologic findings noted

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity:

In an acute oral toxicity study (BASF 1988, 10A0172/881066) similar to OECD 401, groups of 5 Wistar rats per sex were given a single oral dose of the test item in CMC at doses of 464, 1000 and 2150 mg/kg bw and observed for 14 days. No mortality was observed in the lowest dosing group. 4 males and all females died at 1000 mg/kg bw. All animals died in the highest dosing group. Based on these results, the LD50 value of the test item is > 464 and < 1000 mg/kg bw.

Acute inhalation toxicity:
In an acute inhalation toxicity study (BASF 1988, 10I0172/8887026), groups of six (3/sex) Wistar rats were exposed to a mean test item concentration of 0.43 mg/L for 7 hours. During the exposure period intermittently breathing, increased masticatory movement and snout wiping was observed. After the exposure time and within the observation period of 14 days no animals have died and no abnormalities was observed. An LC50 could not be determined.

Acute dermal toxicity:
In an acute dermal toxicity study (BASF 1988, 11A0172/881067) similar to OECD 402, groups of five Wistar rats per sex were dermally exposed to a limit dose of 2000 mg/kg of the unchanged test item. The test substance was applied to the dorsal and dorsolateral parts of the trunk (about 50 cm²) and covered by semi-occlusive dressing for 24 hours. The animals were observed for 14 days. No animals died and no abnormalities were observed within the observation period. Thus, the LD50 vaule is > 2000 mg/kg.

Justification for selection of acute toxicity – oral endpoint
Only available study for this endpoint performed similar to guideline.

Justification for selection of acute toxicity – inhalation endpoint
Only available study for this endpoint performed.

Justification for selection of acute toxicity – dermal endpoint
Only available study for this endpoint performed similar to guideline.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014 as cat. 4, H302, harmful if swallowed.