Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

  Summary results of the key studies are as follows:
·	Skin irritation potential (rabbit): slightly irritating (R. Truhaut, 1974))
·	Eye irritation potential (rabbit): irritating (R. Truhaut, 1974))

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)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of non diluted sample
Duration of treatment / exposure:
4 hours
Observation period:
24 and 72 hours
Number of animals:
6 rabbits
Details on study design:
0.5 ml of heptanol was applied on 6 rabbits with intact skin and 6 rabbits with or abraded skin.
SCORING SYSTEM: according to the DRAIZE scoring.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h+72h
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h+72 h
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h+72h
Score:
0.75
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h+72h
Score:
0.25
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Interpretation of results:
slightly irritating
Remarks:
Migrated information not classified. Criteria used for interpretation of results: EU
Conclusions:
n-heptanol is considered as a slightly irritant.
Executive summary:

The acute dermal irritation of n-heptanol-1 was evaluated in rabbits according to OECD 404 guideline. n-heptanol-1 was applied undiluted to the skin of 6 New-Zealand White albino rabbits and held in contact for 4 hours by means of a semi-occlusive dressing. Mean scores over 24, and 72 hours were 0.75 and 0.25 for erythema and for edema, respectively. Under these experimental conditions, n-heptanol 1 was considered a slightly irritant when applied topically to rabbits.

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
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: non exposed eye
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
6 rabbits
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.16
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.94
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 7 days
Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
n-heptanol-1 is considered as irritating to eyes.
Executive summary:

The potential of n-heptanol-1 to induce ocular irritation was evaluated in rabbits according to OECD (No. 405) guideline. A single dose of 0.1mL of the undiluted test item was instilled into the conjunctival sac of the eye of 6 rabbits. The eyes were not rinsed after administration of the test item.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration. Mean scores calculated over 24, 48 and 72 hours were 0.22 for chemosis, 0.94 for redness of the conjunctiva, 0.0 for iris lesions and 1.16 for corneal opacity. We observed that the test item indiced slght opcity of the cornea with a slght irritation of the conjonctive. The irritation is at maximum at 72 hours and reverse progressively. 4/6 rabbits did not present signs of irritation after 7 days. Under these experimental conditions, n-heptanol-1 was irritant when administered by ocular route to rabbits.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation study

The acute dermal irritation of n-heptanol-1 was evaluated in rabbits according to OECD 404 guideline. n-heptanol-1 was applied undiluted to the skin of 6 New-Zealand White albino rabbits and held in contact for 4 hours by means of a semi-occlusive dressing. Mean scores over 24, and 72 hours were 0.75 and 0.25 for erythema and for edema, respectively. Under these experimental conditions, n-heptanol 1 was considered slightly irritant when applied topically to rabbits.

Eye irritation

The potential of n-heptanol-1 to induce ocular irritation was evaluated in rabbits according to OECD (No. 405) guideline. A single dose of 0.1mL of the undiluted test item was instilled into the conjunctival sac of the eye of 6 rabbits. The eyes were not rinsed after administration of the test item.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration . Mean scores calculated over 24, 48 and 72 hours were 0.22 for chemosis, 0.94 for redness of the conjunctiva, 0.0 for iris lesions and 1.16 for corneal opacity. WE observed that the test item indiced slght opcity of the cornea with a slght irritation of the conjonctive. The irritation is at maximum at 72 hours and reverse progressively. 4/6 rabbits did not present signs of irritation after 7 days. Under these experimental conditions, n-heptanol-1 was irritant when administered by ocular route to rabbits.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

According to REGULATION (EC) No 1272-2008:

Skin irritation: not classified

The mean scores for erythema and oedema over 24, 48 and 72 hours obtained were below the threshold for classification (>= 2.3). The slight skin irritation observed was not fully reversible within 7 days.

Eye irritation: Irritant, category 2

The mean scores calculated over 24, 48 and 72 hours were 1.16 for corneal opacity (thresholf fo classification >=1 for 2/3 animals).

The slight ocular opacity was not fully reversible within 7 days in only 2/ 6 animals.. No observation were performed after the 7-day observation period, therefore we are unable to conclude on the reversibility of the effects. However taking into account the ocular toxicity of comparable compound (hexanol, octanol are classified ocular irritant category 2), it is concluded that heptanol is classified irritant category 2).