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Administrative data

Description of key information

The test substance was corrosive to the skin and eye in all studies performed (skin 3x, eye 1x). The test substance was irritating to the respiratory tract in an GLP compliant, OECD 412 guideline, repeated dose inhalation toxicity study.

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other: Non-guideline study, non-GLP, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment
Reference:
Composition 0
Principles of method if other than guideline:
Two Vienna White rabbits were treated for 3 minutes, 1 hour, and 4 hours, respectively, with the test substance under occlussive conditions. After the application time, the skin was washed with Lutrol or Lutrol/water (1:1) and animals were observed for 8 days.
GLP compliance:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M.Gaukler, 6050 Offenbach
- Weight at study initiation: 3.1, 2.9, 3.6 kg for 4 h, 1 h and 3 min test respectively
- Diet: ad libitum, standard diet Sniff K, standard diet for rabbits and guinea pigs
- Water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
3 min, 1 h and 4 h
Observation period:
8 days
Number of animals:
2 per exposure time
Details on study design:
TEST SITE
- Area of exposure: dorsal skin (2 x 2 cm)
- Type of wrap if used: rubber sheet, fixed with adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol or lutrol/water 1:1 w/w
- Time after start of exposure: 3 min, 1 h or 4 h

OBSERVATION TIME POINTS
- immediately after exposure, and at 1, 2, and 8 days after exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
2.75
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 3 minutes
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 3 minutes
Irritant / corrosive response data:
- 3 minute test: Immediately after exposure slight erythema and edema was observed. One and two days after exposure severe erythema, strong to severe edema and necrosis was observed. After 8 days severe edema, slight erythema and necrosis was observed.
- 1 hour test: severe erythema and necrosis were observed at all time points in both animals. Immediately after exposure slight edema was observed. One and two days after exposure strong to severe edema was observed. Eight days after exposure slight edema was observed in one animal.
- 4 hour test: slight edema, severe erythema and necrosis were observed at all time points in both animals.
Other effects:
No systemic effects observed.
Interpretation of results:
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: Non-guideline study, non-GLP, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment
Reference:
Composition 0
Principles of method if other than guideline:
According to internal BASF guideline
GLP compliance:
no
Test material information:
Composition 1
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
8 days
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
1
Remarks on result:
other: Irreversible effects on the eye were observed 8 days after exposure
Irritant / corrosive response data:
After 1 hour: Chemosis, conjunctivae and slight corneal opacity were observed.
After 24 hours: Chemosis, conjunctivae and corneal opacity were observed.
After 8 days: Conjunctivae, slight corneal opacity and scars were observed.
Interpretation of results:
corrosive
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation/corrosion

Three studies are available in which the potential to cause irritation/corrosion to the skin was evaluated. In the first study (BASF 1979) two Vienna White rabbits were treated for 3 minutes, 1 hour, and 4 hours, respectively, with 2,5-dihydrofuran under occlusive conditions. After the application time, the skin was washed with Lutrol or Lutrol/water (1:1) and animals were observed for 8 days. Severe erythema, strong to severe edema and necrosis were observed in all exposure groups within 1 to 2 days after exposure. Effects were not fully reversible within 8 days. It was therefore concluded that the test substance is corrosive to the skin. In the second study (BASF 1959) one rabbit was treated for 1 minute, 15 minutes or 20 hours, respectively, with 2,5-dihydrofuran. Slight redness and scaling were observed after 1 minute of exposure. Slight redness and slight edema were observed 24 hours after exposure, and scaling and crusts were observed within 8 days of exposure, in animals exposed for 15 minutes. In animals exposed for 20 hours necrosis was observed 24 hours after exposure. In a third study (EKCO 1963) guinea pigs were exposed to 2,5-hydrofuran. Staining, moderate edema, erythema, and necrosis was observed. Small eschars or scarring was observed 1 week after exposure.

 

Eye irritation

The potential to cause damage to the eye was assessed in a study (BASF 1959) in which rabbits were subjected to 2,5-hydrofuran. Chemosis, conjunctivae, and corneal opacity was observed from 1 hour after the start of exposure. These effects were not fully reversible within 8 days. In addition, scars were observed 8 days after exposure.

Respiratory irritation

In a GLP compliant OECD 412 guideline repeated dose inhalation toxicity study, five Sprague Dawley rats per sex per dose were exposed to 125, 400 or 1250 ppm. Exposure-related changes observed in the nasal passages consisted of squamous metaplasia of the respiratory epithelium, degeneration of the olfactory epithelium, and serocellular exudate in the middle or dorsal meatus for the 400 and 1250 ppm groups. Based on this it was concluded that the substance is respiratory irritating.


Justification for selection of skin irritation / corrosion endpoint:
Three studies are available in which the potential to cause irritation/corrosion to the skin was evaluated. The study in which the most relevant exposure times were used was chosen as key study.

Justification for selection of eye irritation endpoint:
One study is available in which the potential to cause eye damage was evaluated. This study is adequate for covering this endpoint.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Based on the corrosive skin effects observed 1 to 2 days after exposure in animals that were exposed for 3 minutes, 2,5-hydrofuran has to be classified as Skin corrosive: Cat 1B: H314: Causes severe skin burns and eye damage in with accordance EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and C: R34: Causes burns in accordance with Directive 67/548/EEC (DSD).

Based on the corrosive eye effects observed 2,5-hydrofuran has to be classified as Eye damage 1: H318: Causes serious eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and Xi: R41: Risk of serious damage to eyes in accordance with Directive 67/548/EEC (DSD).

Based on the potential to cause repiratory irritation 2,5-hydrofuran has to be classified as STOT 3: H335: May cause respiratory irritation in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and Xi: R37: Irritating to the respiratory system in accordance with Directive 67/548/EEC (DSD).