1,4-bis(vinyloxy)butane

Endpoint summary

Description of key information

Skin irritation: with 20 h exposure time well-defined erythema and edema (Grade 2) were observed after 24 h; after 8 days only scaling was reported
Eye irritation: slight reddening of conjunctivae (Grade 1) was observed after 24 h (fully reversible within 8 days)
Not to be classified as skin or eye irritating.

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

Study period:

1973-12-18 to 1975-03-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable, method eqivalent or similar to guideline study.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

method applied according to BASF-internal standard

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 1973-12-18 To: 1973-12-27

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: ca. 1 mL

Duration of treatment / exposure:

The test substance was applied for 1 min, 5 min, 15 min and 20 h

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used:
Application to ear: a cotton ball soaked with test item was fixed to the ear
Application to back: a small piece of cloth was fixed to the back with the help of a gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing: After the short-term applications the test substance was washed off with Lutrol; after the 20-hour application the test substance was not washed off.
- Time after start of exposure: 1 min, 5 min and 15 min

SCORING SYSTEM: observed were the parameters erythema, edema, scaling, and necrosis
Grading system:
"reizlos" Ø: considered as equivalent to Grade 0 (no irritating effect) according to OECD Guideline 404
"fraglich" (+): considered as equivalent to Grade 1 (very slight erythema (barely perceptible)) according to OECD Guideline 404
"leicht" +: considered as equivalent to Grade 2 (well-defined effect) according to OECD Guideline 404
"stark" ++: considered as equivalent to Grade 3 (moderate (to severe)) effect according to OECD Guideline 404
"sehr stark" +++: considered as equivalent to Grade 4 (severe effect) according to OECD Guideline 404

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

other: incipient scaling after 8 days

Remarks on result:

other: 20-hour application to back

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

other: incipient scaling after 8 days

Remarks on result:

other: 20-hour application to back

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

other: incipient scaling after 8 days

Remarks on result:

other: 20-hour application to back

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

other: incipient scaling after 8 days

Remarks on result:

other: 20-hour application to back

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

other: incipient scaling after 8 days

Remarks on result:

other: 20-hour application to back

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

other: incipient scaling after 8 days

Remarks on result:

other: 20-hour application to back

Irritant / corrosive response data:

Application to ear for 20 hours resulted in Grade 3 erythema and edema after 24 hours. Erythema and edema not reported on day 8, however eschar was observed.

Table of results (20 h application of test item) based on grading system as applied in the study report

   

	time	animal 1	animal 2
erythema	24 h	+	+
	8 d	Ø	Ø
edema	24 h	+	+
	8 d	Ø	Ø
scaling	24 h	Ø	Ø
	8 d	+	+

 

Table of results (20 h application of test item) translated into the grading system as applied in OECD Guideline 404

  

	time	animal 1	animal 2
erythema	24 h	2	2
	8 d	0	0
edema	24 h	2	2
	8 d	0	0
scaling	24 h	0	0
	8 d	2	2

 

Interpretation of results:

slightly irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973-12-18 to 1975-03-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable, method equivalent or similar to guideline study.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

method applied according to BASF-internal standard

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.11 - 3.32 kg
- Housing: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 1973-12-18 To: 1973-12-27

Vehicle:

unchanged (no vehicle)

Controls:

other: 0.05 mL of a NaCl solution was applied into the other eye of the same animal

Amount / concentration applied:

0.05 mL

Duration of treatment / exposure:

Single instillation into the conjunctival sac of the right eyelid

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was not washed out

SCORING SYSTEM: observed were the parameters redness conjunctivae, chemosis, cornea opacity, and necrosis
Grading system for cornea and chemosis:
"reizlos" Ø: considered as equivalent to Grade 0 according to OECD Guideline 405
"fraglich" (+): considered as equivalent to Grade 1 according to OECD Guideline 405
"leicht" +: considered as equivalent to Grade 2 according to OECD Guideline 405
"stark" ++: considered as equivalent to Grade 3 effect according to OECD Guideline 405
"sehr stark" +++: considered as equivalent to Grade 4 according to OECD Guideline 405

Grading system for conjunctivae:
"reizlos" Ø: considered as equivalent to Grade 0 according to OECD Guideline 405
"leicht" +: considered as equivalent to Grade 1 according to OECD Guideline 405
"stark" ++: considered as equivalent to Grade 2 effect according to OECD Guideline 405
"sehr stark" +++: considered as equivalent to Grade 3 according to OECD Guideline 405

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: no irritating effects observed

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: no irritating effects observed

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: no irritating effects observed

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: no irritating effects observed

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: no irritating effects observed

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: no irritating effects observed

Irritant / corrosive response data:

After 1 h the treated eye was covered by a smeary layer (reversible after 8 days)

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

The skin irritation was tested in 1973 by a study equivalent or similar to OECD Guideline 404. The test substance was applied in a single dose (occlusive) to the clipped skin (back and ear) of an experimental animal; untreated skin areas of the test animal served as the control. The degree of irritation was read and scored at 1 min, 5 min, and 15 min (treated skin was washed). In addition skin was treated for 20 hours and not washed; these observations were recorded after 24 hours and 8 days. With 20 hours treatment the test item exhibited well-defined erythema and edema (Grade 2) after 24 hours. On day 8 these effects were reversed, with scaling still being reported.

Eye irritation:

The eye irritation was tested in 1973 with a study equivalent or similar to OECD Guideline 405. The test substance was applied in a single dose to one of the eyes of the experimental animal; the untreated eye served as the control. The degree of eye irritation was evaluated by scoring lesions of conjunctiva and cornea at 24 hours and 8 days. A slight reddening of the conjunctivae (Grade 1) was observed after 24 hours, which proved to be fully reversible within the 8 days observation period.

Justification for selection of skin irritation / corrosion endpoint:
Applicable to endpoint study, method equivalent or similar to guideline study.

Justification for selection of eye irritation endpoint:
Applicable to endpoint study, method equivalent or similar to guideline study.

Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

Skin irritation

 

Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance has to be classified for skin irritation (R38) under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The reported effects were less severe than the classification criteria as set out in EC Regulation 1272/2008 (mean value of ≥ 2.3 - ≤ 4.0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal). The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

 

 

Eye irritation

 

Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under Directive 67/548/EEC.As a result and according to the harmonised Annex I classification the substance is not considered to be classified for eye irritation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The reported effects were less severe than the minimum classification criteria for conjunctival redness >=2 as set out in EC Regulation 1272/2008. No further eye irritating effect observed. 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 not to be classified for eye irritation.