3,3'-[butane-1,4-diylbis(oxy)]bispropanamine

Endpoint summary

Description of key information

Skin: corrosive (BASF, 1972, XXII/115)
Eye: corrosive (BASF, 1972, XXII/115)

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

BASF test: Animals were exposed for 1, 5 and 15 min and 20 h, respectively; occlusive dressing was used; animals were observed for only 8 days

GLP compliance:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report): Butandiol-di(aminopropyl)-ether
- Physical state: liquid

Species:

rabbit

Strain:

Vienna White

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

An application site of 2.5 cm x 2.5 cm was covered with the liquid test substance

Duration of treatment / exposure:

1, 5, 15 min and 20 h

Observation period:

8 days

Number of animals:

2 per time point

Details on study design:

After application time, the skin was washed with water

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 min exposure - next day-observation

Reversibility:

not fully reversible within: 8 days (one animal)

Remarks on result:

other: Slight erythema were observed on next day.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 5 min exposure - 24 h post exposure

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Moderate to strong erythema was observed one hour following treatment; soft, red-brownish necrosis was visible 24 h after exposure; hard, leather-like necrosis was observed 8 days later.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 5 min exposure - 24 h post exposure

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Slight erythema and edema.

Irritation parameter:

other: necrosis

Basis:

mean

Time point:

other: 15 min exposure - 24 h post-exposure

Reversibility:

not reversible

Remarks on result:

other: Lesions were not reversible until the end of the observation period (day 8), when leather-like necrosis was present in both animals.

Irritation parameter:

other: necrosis

Basis:

mean

Time point:

other: 20 h exposure - 24 h post exposure

Reversibility:

not reversible

Remarks on result:

other: Lesions were not reversible and the formation of transverse folds was additionally visible 8 days after substance application.

Irritant / corrosive response data:

1 min exposure: slight erythema in both animals the next day; no abnormalities were detected in one animal 8 days after substance application, whereas strong scale formation was present in the other rabbit at day 8 post-exposure.
5 min exposure: moderate to strong erythema was observed in one rabbit one hour following treatment; soft, red-brownish necrosis was visible 24 h post-exposure; hard, leather-like necrosis was observed in this animal 8 days later; the other rabbit showed slight erythema and edema 24 h post-exposure; 8 days later, slight erythema was still visible and strong scale formation was present
15 min exposure: strong, leather-like, hard necrosis in one animal and soft, anemic, parchmenty necrosis in the second rabbit 24 h following substance application; these lesions were not reversible until the end of the observation period (day 8), when leather-like necrosis was present in both animals
20 h exposure: hard, leather-like, overall necrosis in both animals 24 h following substance application; lesions were not reversible and the formation of transverse folds was additionally visible 8 days after substance application.

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

BASF test: only 8 das observation period; eyes were not washed out after 24 h

GLP compliance:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report): Butandiol-di(aminopropyl)-ether
- Physical state: liquid

Species:

rabbit

Strain:

Vienna White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

50 µl of the test item were applied to the right eye; the left eye serves as control and was treated with 50 µl NaCl; the test substance was not washed out after 24 h

Duration of treatment / exposure:

The test item was not washed out and remained in the eye for the entire course of the experiment

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: cannot be determined at day 8 due to severe corrosion

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Max. score:

3

Remarks on result:

other: strong erytheme at day 8

Irritant / corrosive response data:

Test item application had severe effects on rabbit eyes; after 8 days, severe pus formation can be observed accompanied by staphylom and scar formation, severe erythema and marked chemosis. Pus formation was observed during the entire course of the experiment; soft necosis was observed 24 and 48 and hard necrosis 72 h following test item application; due to the severe lesions, redness of the conjunctivae could not be assessed.

Irritation scores:

Time	Cornea		Conjuctivae		Iris		Chemosis
	A1	A2	A1	A2	A1	A2	A1	A2
24 h	3	3	n.a.	n.a.			2	3-4
48 h	3	3	n.a.	n.a.	2		3-4	3-4
72 h	3	3	n.a.	n.a.	2		2	3-4
8 d			2	2	2		2	2

A1/A2: Animal 1/Animal 2

n.a.: not assessable

No data concerning iritis for animal 2

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:

The skin irritating/corrosive potential of the test item was analysed in rabbits similar to OECD guideline 404 (BASF AG, 1972). A 2.5 x 2.5 cm cloth coated in the test substance was applied to the back of two rabbits for 1, 5, 15 min and 20 h (occlusive dressing). Animals were observed for the occurence of skin lesions for eight days and the severity noted 1 hour, 24 hours and 8 days following substance application. The following observations were made:

1 min exposure: slight erythema in both animals the next day; no abnormalities were detected in one animal 8 days after substance application, whereas strong scale formation was present in the other rabbit at day 8 post-exposure.

5 min exposure: moderate to strong erythema was observed in one rabbit one hour following treatment; soft, red-brownish necrosis was visible 24 h post-exposure; hard, leather-like necrosis was observed in this animal 8 days later; the other rabbit showed slight erythema and edema 24 h post-exposure; 8 days later, slight erythema was still visible and strong scale formation was present

15 min exposure: strong, leather-like, hard necrosis in one animal and soft, anemic, parchmenty necrosis in the second rabbit 24 h following substance application; these lesions were not reversible until the end of the observation period (day 8), when leather-like necrosis was present in both animals

20 h exposure: hard, leather-like, overall necrosis in both animals 24 h following substance application; lesions were not reversible and the formation of transverse folds was additionally visible 8 days after substance application.

In summary, after a 5-min exposure to the test item erythema but no necrosis was seen on the skin of one rabbit at the 1 hour reading. Subsequent to an exposure of >= 15 min full thickness necrosis was observed in all test animals. These results demonstrate that the substance fulfills the classification criteria for skin corrosion, category 1B according to Regulation (EC) 1272/2008 (CLP).

Eye irritation:

The eye irritating/corrosive potential of the test item was analysed in rabbits similar to OECD guideline 405 (BASF AG, 1972).

The right eyes of two rabbits were treated with 50 µl test substance; the substance was not washed out the following day. The conjunctivae, iris and cornea were observed for 8 days and changes noted after 24, 48, 72 h and 8 days. Both animals showed a milky opacity of the cornea, iritis and severe chemosis over the entire course of the experiment. Reddening of the conjunctivae was not assessable due to severe other lesions. Furthermore, necrosis and staphylom formation were observed. The mean cornea score (after 24, 48 and 72 h; both rabbits) was 3, the iris score 2 and the chemosis score 3. Lesions were not fully reversible within 8 days (conjunctivae score = 2, Iris score = 2 and chemosis score = 2).

Justification for classification or non-classification

Based on the results of experimental studies and according to criteria of Regulation (EC) No 1272/2008 (CLP) the registered substance is classified and labelled as follows:

Skin corrosion Cat 1B, H314 - causes severe skin burns and eye damage.