N,N-dibutylformamide

Endpoint summary

Description of key information

Skin irritation: corrosive

Eye irritation: severe damaging

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Qualifier:

no guideline followed

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

Body weight: female 3.23 kg, male 2.41 kg
The animals were offered a standardized animal laboratory diet.

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

ca. 1 mL

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

2 (one female, one male)

Details on study design:

Application site: back
Application area: 1 x 1 cm
The test substance was washed off with Lutrol 100% and 50%.

Histopathology: heart, lung, trachea, liver, spleen, kidney, central nervous system, lymph node system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: necrosis leather-like

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: necrosis leather-like

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Other effects:

The skin findings were pathologically confirmed (after incising of the skin).
Necropsy: No substance-related organ changes.
But in liver parasitic attack was observed (female), in male ulcerous phinitis was observed.

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

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

Qualifier:

no guideline followed

Principles of method if other than guideline:

according to Fed. Reg. 38, No. 187, § 187, § 1500.42, 1962 (Draize test)

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

Mean body weight: 3.1 kg
The animals were offered a standardized animal laboratory diet.

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

3 (2 male, 1 female)

Details on study design:

The test substance was not washed off.

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritant / corrosive response data:

Symptoms:
Animal no.1+2; time period 24-72 hours (no.1 until 8 days): Narrowed pupil
Animal no.3; time period 72 hours: Narrowed pupil
Animal no.1 +2, time period 72 hours – 8 days: Scars

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A weight of evidence approach was made for this endpoint. In a well-documented and scientifically reliable study the test substance was administrated to rabbits for 4 hour. 2 animals were used. The scores for erythema and edema were recorded over the observation period of 8 days. The mean erythema score after 24 and 48 hours for both animals was determined to be 4, which was not fully reversible within 8 days. Leather-like necrosis was observed. The mean edema score (24/48 hours) was determined to be 3 for animal no. 1, for the second animal the mean edema score was 2. The edema was fully reversible within 8 days for both animals. Based on this result the test substance was determined to be corrosive to the skin (1979, reliability score: 2).

In another study the test substance was administrated to rabbits for one hour. 2 animals were used. The scores for erythema and edema were recorded over the observation period of 8 days. The mean erythema score after 24 and 48 hours for both animals was determined to be 2, which was not fully reversible within 8 days. Scuffing was observed. The mean edema score (24/48 hours) was determined to be 2 for both animals. The edema was fully reversible within 8 days. Based on this result the test substance is determined to be corrosive to the skin (1979, reliability score: 2).

Eye irritation

In a Draize eye irritation study the test substance was administrated to rabbits for 24 hours. 3 animals were used. The scores for cornea, iris, conjunctivae redness, chemosis were recorded over the observation period of 8 days. For the evaluation the mean value of the time points 24, 48 and 72 hours for each animal was calculated. The mean cornea opacity score for two animals was determined to be 2, for one animal it was determined to be 1. The cornea opacity was not fully reversible within 8 days in all animals. The mean iris score was for two animals 1 and for one animal 0. The iris score was not fully reversible within 8 days in all animals. The mean conjunctivae redness score was determined to be 2 in all animals. The conjunctivae redness was not fully reversible within 8 days in all animals. The mean chemosis score was determined to be 2 in all animals. The chemosis was not fully reversible within 8 days in all animals. Based on these results the test substance was determined to be irreversible damaging to the eye (1979, reliability score: 2).

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified for skin corr. Cat.1C (H314: "Causes severe skin burns and eye damage") and for eye damage Cat. 1 (H318: "Causes serious eye damage") under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.