Registration Dossier

Administrative data

Description of key information

- skin irritation in-vivo: slightly irritating to the skin of male rabbits (Dunlap, 1958)

- eye irritation in-vivo: irritating to the eyes of rabbits (Jacobs, 1988/1992; Dunlap,1958)

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: peer-reviewed journal
Qualifier:
no guideline followed
Principles of method if other than guideline:
2-Propen-1-ol (0.5ml) was applied to intact and abraded skin (ventral surface) of 3 male albino rabbits. (It is not stated if fur at the treatment site was clipped first.) The application site was covered with gauze under a rubber dam, fastened with adhesive tape.
The test site was examined 24 hr post-application.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
exposure time: 24 h
Observation period:
no data
Number of animals:
3
Irritation parameter:
erythema score
Basis:
other: animal #1 (of 3 animals)
Time point:
24 h
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Slight erythema was present at the application site (intact skin) of one animal.

Slight erythema was present at the application site (intact skin) of one animal when the patch was removed (24 hr timepoint) but this had fully resolved by 48 hr. No other reactions were noted.

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the conditions of this test, 2-propen-1-ol was slightly irritating to rabbit skin.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer-reviewed journal
Qualifier:
according to
Guideline:
other: Draize Test
Deviations:
not specified
Principles of method if other than guideline:
2-Propen-1-ol (0.05 ml) was instilled into the left eye of 3 male albino rabbits.
The eyes were examined after 1 hr for signs of irritation (first unstained, then after application of 5% fluorescein sodium). Further examinations were carried our at 24 hr and 48 hr and during the subsequent week.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
1 h
Observation period (in vivo):
1hr, 24 hr and 48 hr
Number of animals or in vitro replicates:
3
Irritation parameter:
other: Conjunctival erythema
Time point:
other: 1 hr
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 1 week
Remarks on result:
other: affecting 3/3 rabbits
Irritation parameter:
other: edema
Time point:
other: 1 hr
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 week
Remarks on result:
other: affecting 1/3 rabbits
Irritation parameter:
other: conjunctival erythema
Time point:
other: 24 h
Score:
> 4 - < 6
Reversibility:
fully reversible within: 1 week
Remarks on result:
other: affecting 3/3 rabbits
Irritation parameter:
other: corneal opacity
Time point:
other: 24 h
Score:
> 5 - < 10
Reversibility:
fully reversible within: 1 week
Remarks on result:
other: affecting 2/3 rabbits
Irritation parameter:
other: iris
Time point:
other: 24 h
Score:
1
Reversibility:
fully reversible within: 1 week
Remarks on result:
other: affecting 1/3 rabbits
Irritation parameter:
other: conjunctival redness
Time point:
other: 48 h
Score:
> 2 - < 6
Reversibility:
fully reversible within: 1 week
Remarks on result:
other: affecting 3/3 rabbits
Irritation parameter:
other: corneal opacity
Time point:
other: 48 h
Score:
5
Reversibility:
fully reversible within: 1 week
Remarks on result:
other: affecting 1/3 rabbits
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the conditions of this test, 2-propen-1-ol was irritating to rabbit eye producing reversible conjunctival redness, iridial injection and corneal opacity that persisted at least 48 hr post instillation.
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer-reviewed journal
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
score of iris was not recorded
Principles of method if other than guideline:
The test was carried out in two phases with rabbits, seperated by about 6 months. In the first phase, the rabbits were tested and scored clinically. In the second phase in addition to the clinical examination corneal swelling was also measured using a ultrasonic pachometer.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
1 s (single application of test material)
Observation period (in vivo):
4, 24, 48, 72, 96 and 168 h
Number of animals or in vitro replicates:
6 (3 in the first phase and 3 additional in the second)
Irritation parameter:
other: erythema
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
2.89
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: 6 rabbits
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
1.23
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: 6 rabbits
Irritation parameter:
other: corneal opacity
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
2.09
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: 6 rabbits
Irritation parameter:
other: Corneal swelling thickness
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
76
Max. score:
100
Reversibility:
not specified
Remarks on result:
other: 3 rabbits
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the conditions of this study, allyl alcohol is considered to be irritating in the eyes of rabbits.
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer-reviewed journal
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
no data
Observation period (in vivo):
96 h
Number of animals or in vitro replicates:
6
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 hrs
Score:
> 2.5
Max. score:
3
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hrs
Score:
1
Max. score:
2
Reversibility:
not specified
Irritation parameter:
other: corneal opacity
Basis:
mean
Time point:
other: 24/48/72 hrs
Score:
2.07
Max. score:
4
Reversibility:
not specified

Compound Tested: 2-Propenol; (RN) 107-18-6; Ally1 alcohol

Compound Preparation: Neat

Time after application 4 Hr 24 Hr 48 Hr 72 Hr 96 Hr
Mean Score of Conjunctivitis (3 maximum) 1.9 2.7 3.0 2.9 2.8
Mean Score of Chemosis (4 maximum) 1.7 1.5 1.0 0.3 0.3
Mean Score of Iritis (2 maximum) 1.0 1.0 1.0 1.0 0.7
Mean Score of Corneal Opacity (4 maximum) 1.2 1.7 2.2 2.3 2.5
Mean Surface of Corneal Damage (100% maximum) 90 84 56 25 28

Classification according to the EC criteria in EEC (1983). Annex VI, part IID of the Council directive 79/831/EEC (19 September 1983, Irritating to eyes (mean of conjunctivitis over 24/48/72 Hrs > 2.5, mean of iritis over 24/48/12 Hrs = 1, mean of corneal opacity over 24/48/72 Hrs >2)

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
irritating
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin irritation: according to CLP classification criteria, the substance meets the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008: Category 2; H315: causes skin irritation.

The CLP classification is in accordance with the one listed for Allyl alcohol in Annex VI (EC No. 1272/2008).

Eye irritation: according to CLP classification criteria, the substance meets the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008: Category 2; H319: causes serious eye irritation.

The CLP classification is in accordance with the one listed for Allyl alcohol in Annex VI (EC No. 1272/2008).


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