Tetrahydrofurfuryl alcohol

Endpoint summary

Description of key information

The key study for skin irritation found the test material not irritating (WIL 1992). It was conducted according to a protocol equivalent to the current OECD guideline, and in compliance with GLP.

The key study for eye irritation found the test substance irritating to the eyes of rabbit, based on corneal opacity of ≥1 in 3 animals, iritis of ≥1 in 4 animals and conjuntival chemosis of ≥2 in 3 animals (WIL 1992). The study was reliable and compliant with GLP.

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:

7 - 10 October 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Qualifier:

according to guideline

Guideline:

other: Japanese Agricultural Chemicals Laws and regulations Testing Guidelines for Toxicology Studies published by the Society of Agricultural Chemical Industry, under the Ministry of Agriculture, Forestry and Fisheries

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton research Products, Inc. Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 2638 - 2838 grams
- Housing: Individual suspended mesh - bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 52-62
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6F

Details on study design:

TEST SITE
- Area of exposure: the back of rabbits
- Type of wrap if used: gauze patches that were overwrapped with a gauze binder and secured with Dermiform tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The sites were wiped with disposable paper towels moistened with deionized water.
- Time after start of exposure:

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test material induced very slight erythema in three rabbits. There was no oedema. All erythema completely subsided by day 3 or earlier. There were no other dermal findings.

Other effects:

None of the rabbits died. There were no significant body weight changes during the study period.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was found not irritating to the skin of rabbits in a reliable study conducted according to current guideline and in compliance with GLP.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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:

October 8 - 30, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products Inc., Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 2549-3004 grams
- Housing: Individual suspended mesh-bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 42-74
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

4 males
2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: UV-light / fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

ca. 0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

>= 1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

ca. 0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

>= 1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

>= 1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

ca. 0.5

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

not reversible

Remarks:

minor conjunctival irritation persisted to termination in one animal. Individual animal data are missing

Remarks on result:

other: individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

not reversible

Remarks:

minor conjunctival irritation persisted to termination in one animal. Individual animal data are missing

Remarks on result:

other: individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

individual animal data are missing - Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: individual animal data are missing

Remarks:

Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal

Irritant / corrosive response data:

Conjunctival irritation was observed in the treated eye of all animals, including positive reactions for four animals. Iridial and corneal irritation were present in the treated eye of five animals, respectively. All iridial and corneal irritation completely subsided by day 7 and day 21, respectively, or earlier. Conjunctival irritation completely subsided by day 7 or earlier for five rabbits. Minor conjunctival irritation persisted through study termination for one animal.

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

The test substance was found irritating to the eyes of rabbit, based on corneal opacity of ≥1 in 3 animals, iritis of ≥1 in 4 animals and conjuntival chemosis of ≥2 in 3 animals.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The key study for skin irritation found the test material not irritating to the skin of rabbits in a reliable study conducted according to current guideline and in compliance with GLP (WIL 1992). The test material induced very slight erythema in three rabbits. There was no oedema. All erythema completely subsided by Day 3 or earlier. There were no other dermal findings. None of the rabbits died. There were no significant body weight changes during the study period. A reliability 4 supporting study was also available, which supported the key findings (Lashmar et al., 1989).

The key study for eye irritation was conducted according to a protocol equivalent to current OECD guideline, and in compliance with GLP (WIL 1992).Conjunctival irritation was observed in the treated eye of all animals, including positive reactions for four animals. Iridial and corneal irritation were present in the treated eye of five animals, respectively. All iridial and corneal irritation completely subsided by Day 7 and Day 21, respectively, or earlier. Conjunctival irritation completely subsided by Day 7 or earlier for five rabbits. Minor conjunctival irritation persisted through study termination for one animal. The test substance was found to be irritating to the eyes of rabbits, based on corneal opacity of ≥1 in 3 animals, iritis of ≥1 in 4 animals and conjunctival chemosis of ≥2 in 3 animals. Two reliability 4 supporting studies were also available for review, which supported the findings of the key study (Conquet et al., 1976, Jacobs et al., 1988).

Justification for classification or non-classification

Based on the available information, no classification is required for THFA for skin irritation. In accordance with EC Regulation No. 1272/2008, THFA is classified as Category 2: Irritating to eyes, H319: Causes serious eye irritation.