Bis(2-dimethylaminoethyl)(methyl)amine

Endpoint summary

Description of key information

Skin irritation/corrosion: study equivalent or similar to OECD Guideline 404, Vienna White rabbit m/f, 2 animals, occlusive coverage, observation 8 days, Result: Category 1B (corrosive).
Eye irritation:  study equivalent or similar to OECD Guideline 405, Vienna White rabbit m/f, 2 animals, single application w/o rinsing, observation 8 days, Result: Category 1 (irreversible effects on the eye).

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:

other: Comparable to guideline study with acceptable restrictions (limited documentation, occlusive treatment, no data on substance purity)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(limited documentation, 1, 5, 15 min and 20 h exposure duration, occlusive treatment, no scoring at 72 h)

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

- Source: Gaukler
- Weight at study initiation: 2.94 kg (male), 3.78 kg (female)

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated site served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: area of application: 2.5 x 2.5 cm
- Concentration (if solution): 100%

Duration of treatment / exposure:

1, 5, 15 min and 20 h

Observation period:

8 days (reading intervals: upon removal of test patch, 24 h, 48 h, 5 d, 7 d, and 8 d after start of treatment)

Number of animals:

2 (20 h exposure only in 1 animal)

Irritation parameter:

other: necrosis

Basis:

animal #1

Remarks:

(5 min exposure)

Time point:

other: 24 h

Remarks on result:

other: non-reversible, leather-like, black necrosis

Irritation parameter:

other: necrosis

Basis:

animal #2

Remarks:

(5 min exposure)

Time point:

other: 24 h

Remarks on result:

other: non-reversible leather-like, red-brown necrosis

Skin irritation:

Exposure duration	Readingpoint	Animal 1			Animal 2
		Ery	Ed	Remarks	Ery	Ed	Remarks
1 min	Day 0	2	0	Blotchy necrosis	2	-	blotchy
	24 h	2	2	Necrosis, ecchymosis	-	-	Blotchy necrosis
	48 h	-	-	Blotchy necrosis	-	-	Blotchy necrosis
	Day 5	-	-	Parchmenty necrosis	-	-	Parchmenty necrosis
	Day 7	-	-	Scaling	-	-	Scaling
	Day 8	-	-	Necrosis	-	-	Scaling
5 min	Day 0	3	-	Ecchymosis	2	-	Brownish
	24 h	2	-	Leather-like, black necrosis	-	-	Leather-like, red-brown necrosis
	48 h	-	-	Leather-like, hard necrosis	-	-	Leather-like, red-brown necrosis
	Day 5	-	-	Hard, movable necrosis	-	-	Leather-like, red-brown necrosis
	Day 7	-	-	Hard, movable necrosis	-	-	Leather-like/hard red-brown necrosis
	Day 8	-	-	Hard, movable necrosis	-	-	Leather-like/hard, red-brown necrosis
15 min	Day 0	3	-	Ecchymosis, yellow	2	-	Brownish, overleaping necrotic centre
	24 h	2	-	Leather-like, black necrosis	-	-	Hard, movable black necrosis
	48 h	-	-	Leather-like, black necrosis	-	-	Hard, movable black necrosis
	Day 5	-	-	Leather-like necrosis	-	-	Hard, movable, black necrosis
	Day 7	-	-	Leather-like necrosis	-	-	Hard, movable black necrosis
	Day 8	-	-	Leather-like necrosis	-	-	Hard, movable black necrosis
20 h	24 h	2	-	Soft, black, anaemic necrosis
	48 h	2	-	Hard movable, black necrosis
	Day 5	-	-	Hard, movable necrosis
	Day 7	-	-	Hard, movable necrosis
	Day 8	-	-	Hard, movable necrosis

Ery: Erythema

Ed: Edema

Interpretation of results:

Category 1B (corrosive)

Remarks:

Migrated information

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:

other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on substance purity)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(limited documentation, application amount)

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

- Source: Gaukler
- Weight at study initiation: 3.37 kg (female), 3.32 kg (male)

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent eye served as control

Amount / concentration applied:

50 mm³ of the undiluted test substance

Duration of treatment / exposure:

single application without rinsing

Observation period (in vivo):

8 days (reading after end of treatment at 10 min, 1h, 3 h, 24 h, 48 h, 72 h, 4 d, 7 d and 8 d)

Number of animals or in vitro replicates:

2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 h - 48 h - 72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24 h - 48 h - 72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

iris score

Basis:

mean

Remarks:

(2 animals)

Time point:

other: 24 h - 48 h - 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 h

Score:

0.66

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 h - 48 h

Score:

1.33

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 h - 48 h - 72 h

Score:

2.66

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24 h - 48 h - 72 h

Score:

3.33

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Reading	Animal 1					Animal 2
	Cornea	Iris	Conj	Chem	Remarks	Cornea	Iris	Conj	Chem	Remarks
10 min	2				NMr, NP, S	1				NMw, NP, S
1 h	2			1	NMr, BS	2			1	NMw, BS
3 h	2			2	NMg, BS	3			2	NMr, BS
24 h	3		2	2	NMg, CE	3		2	4	Su, CE
48 h	3			2	NMg, S, N	3		2	2	NMw, Su, CE
72 h	3			4	NMg, Su, CE	3			4	NMg, Su, CE
4 d	3			4	N	3			2	NMr, CE, Su
7 d	3			2	NMg, Su, CE	3			2	NMr, Su, CE
8 d	3			2	N	3			2	NMr, Su, CE

Conj.: Conjunctivae Score

Chem: Chemosis Score

 

NMr: nictitating membrane red-brown; NMg: nictitating membrane grey; NMw: nictitating membrane white; NP: narrowed pupil; S: secretion; BS: bloody secretion

CE: crusted eyelids; N: necrotic eyelids; Su: suppuration

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Both key studies were reliable with restrictions, since there were deviations from the official OECD guidelines.

In skin irritation/corrosion testing, leather-like black necrosis was observed after 5 minute exposure in both animals. Results on corrosivity of the test substance were supported by 3 other studies, including 2 in vivo and 1 in vitro study.

Eye irritation testing showed not-fully reversible, or non-reversible changes of the cornea and conjunctiva.

Justification for selection of skin irritation / corrosion endpoint:
The study with the suitable duration of exposure and selection of the examination times was selected (equivalent or similar to OECD Guideline 404)

Justification for selection of eye irritation endpoint:
one study available, equivalent or similar to OECD Guideline 405

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the results from skin irritation/corrosion and eye irritation testing, the substance is classified as corrosive - Skin Corr. 1B, H314 (Causes severe skin burns and eye damage) and Eye Dam. 1, H318 (Causes serious eye damage) according to the CLP Regulation.