2,2-dimethylpropane-1,3-diamine

Endpoint summary

Description of key information

The test substance is corrosive to skin and eyes.

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:

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

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

Mean body weight: 3 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:

3 min

Observation period:

8 d

Number of animals:

2

Details on study design:

Application area: 2.5 x 2.5
Application site: back of the rabbits
The test substance was washed off with Lutrol.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 3 min

Score:

3

Max. score:

3

Reversibility:

other: severe, not relocatable necrosis after days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 3 min

Score:

3

Max. score:

3

Reversibility:

other: leather-like necrosis after 8 days

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 3 min

Score:

2

Max. score:

2

Reversibility:

not reversible

Irritant / corrosive response data:

The skin findings were macroscopically confirmed by the pathologist.

Animal No.	3 min		1 day		2 days		8 days
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1	3 e	2	4 Np	3	4 Np	2	4 Nh	2
2	3 e	2	4 Np	2	4 Np	2	4 Nl	2

 

e: extending beyond the area of exposure

N: necrosis (p: parchment-like; h: hard/displacable; l: leathery)

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

The test substance is corrosive to skin.

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

Principles of method if other than guideline:

according to Fed. Reg. 38, No. 187, § 1500.42; 1973 (Draize Test)

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

A standardized animal laboratory diet was used.
Mean body weight: 2.8 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

3

Details on study design:

scoring according to Draize

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24

Score:

3

Max. score:

3

Reversibility:

other: after 48 h, the eye was clotty (purulence) and thus could not be estimated

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

1

Reversibility:

other: after 48 h, the eye was clotty (purulence) and thus could not be estimated

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

2

Max. score:

2

Reversibility:

other: after 48 h, the eye was clotty (purulence) and thus could not be estimated

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Readings	Animal	Cornea		Iris	Conjunctiva			Symptoms
		op	ar		red	sw
24 h	1	3	4	1	2	2		Pupil contracted, nictitation membrane, mucosa reddish brown, blood
	2	3	4	1	2	2
	3	3	4	1	2	2
48 h	1	*	*	*	*	3
	2	*	*	*	*	3
	3	4	4	*	2	3
72 h	1	*	*	*	*	3
	2	*	*	*	*	3
	3	4	4	*	2	3
8 days	1	*	*	*	*	3
	2	*	*	*	*	3
	3	*	*	*	*	3

*eye was clotty, could not be estimated

Interpretation of results:

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

Conclusions:

The test substance is corrosive to eyes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a primary dermal irritation study two Vienna White rabbits were dermally exposed to 1.0 mL of undiluted test substance for 3 min under an occlusive dressing (BASF AG, 1979). Animals were then observed for 72 hours. The animals showed severe erythema and edema. According to the results the substance is corrosive to skin.

 

Eye irritation

In a primary eye irritation study (Draize test) 0.1 mL of the unchanged test substance was applied to the eyes of three New Zealand White (BASF AG, 1979). The animals were observed for 8 day. After 24 hours the eyes showed severe corneal opacity and inflammation of the iris. After 48 hours the eyes were clotty, iris score, conjunctiva score and corneal opacity could not be estimated. Based on the results it is concluded that the test substance is corrosive to eyes.

 

 

 

 

 

Justification for classification or non-classification

Based on the results of the skin and eye corrosion testing, the test item is classified and labelled as skin corrosive cat. 1A (H314) and eye damaging cat. 1 (H318) according to Regulation (EC) No 1272/2008 (CLP).