Alcohols, C16-18

Endpoint summary

Description of key information

-The acute eye irritation study (Carter, G., Dharmarajan, V., and Weill, H.  .1975) indicates that Alcohols, C16-18 was not irritating. 
Result: not irritating to eye. Based on the Draize scores reported it is considered that Alcohols, C16-18 is not not an eye irritant according to either EU or GHS criteria.The alcohols with chain lengths of C16-18 are non-irritant to eye. 
- The results of the study (Carter, G., Dharmarajan, V., and Weill, H.  1975) indicate that Alcohols, C16-18 is non-irritant to skin. Following a 24 hour semi-occlusive exposure to rabbit skin Alcohols, C16-18 is classified as non-irritant based on either EU or GHS criteria. The alcohols with chain lengths of C16-18 are non-irritant to skin. 
Result: non-irritant to skin
 - Respiratory irritation 
There is no information available from single or repeated inhalation exposures in laboratory animals or from human experience allowing a conclusion on potential respiratory tract irritation of the aliphatic alcohols.

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Primary Irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the rabbits, clipped free of hair. The six rabbits are used in abraded and intact skin tests. (5 assessed one died).
Single 24-hour application to two sites each on the intact skin of 5 rabbits. After 24 hours exposure, the patches are removed and the resulting reactions are evaluated on the basis of the designated values.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
-rabbit
- Strain: New Zealand White
- Sex: Not reported
- Source: Not reported
- Age: Not reported
- Weight at study initiation: Not reported
- Number of animals: 6 (5 assessed one died)
- Controls: No

Type of coverage:

semiocclusive

Preparation of test site:

other: intact and abraded

Vehicle:

other: Peanut oil

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 (5 assessed one died)

Details on study design:

ADMINISTRATION/EXPOSURE
- Preparation of test substance: 50% in peanut oil
- Area of exposure: Not reported
- Occlusion: semi-occlusive
- Vehicle: Peanut oil
- Concentration in vehicle: 50%
- Exposure period: 24 hours
- Total volume applied: 0.5 ml
- Postexposure period: 72 hours
- Removal of test substance: Not reported

EXAMINATIONS
- Scoring system: Draize
- Examination time points: 24 and 72 hours

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

24 h

Score:

0.5

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

24 h

Score:

0.5

Reversibility:

fully reversible within: 72 hourS

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

24 h

Score:

0.5

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

24 h

Score:

1.5

Reversibility:

fully reversible within: hours post

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

24/48/72 h

Score:

0.7

Reversibility:

other: By 72 hours post exposure erythema scores in 4 of the 5 surviving rabbits were 0, in the 5th rabbit the erythema score had reduced from 2 to 1.

Remarks on result:

other: intact skin .

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

72 h

Score:

0.5

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

72 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

72 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

72 h

Score:

1.5

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6

Time point:

24/48/72 h

Score:

0.8

Reversibility:

other: y 72 hours post exposure erythema scores in 4 of the 5 surviving rabbits were 0, in the 5th rabbit the erythema score had reduced from 2 to 1.

Remarks on result:

other: abraded skin

Irritation parameter:

other: Oedema

Basis:

mean

Remarks:

6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Remarks:

6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Interpretation of results:

other: not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Following a 24 hour semi-occlusive exposure to rabbit skin Alcohols, C16-18 is classified as non-irritant based on either EU or GHS criteria.
The alcohols with chain lengths of C16-18 are non-irritant to skin.

Executive summary:

Following a 24 hour semi-occlusive exposure to rabbit skin Alcohols, C16-18 is classified as non-irritant based on either EU or GHS criteria. The alcohols with chain lengths of C16-18 are non-irritant to skin.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Scoring system:Draize Test

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS: Rabbit
- Strain: New Zealand White
- Sex: not reported
- Source: not reported
- Age: not reported
- Number of animals: 6
- Controls: Untreated eye used as control.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 degree C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Vehicle:

other: peanut oil

Controls:

yes

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

ADMINISTRATION/EXPOSURE
- Preparation of test substance: prepared in vehicle at 40C. The material was a sticky waxy solid and could not be powdered and the melting point was too high to apply without causing heat damage.
- Amount of substance instilled: 0.1 ml
- Vehicle: peanut oil
- Postexposure period: 7 days

EXAMINATIONS
- Scoring system: Draize
- Observation period: 7 days
- Tool used to assess score: not reported.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Conjunctivae (Redness, chemosis, discharge): scored together using the Draize calculation individual scores 4, 4, 2, 4, 0 at 24 hours and 0, 0, 0, 0, 2 at 48 hours.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48 h

Score:

2.8

Reversibility:

fully reversible

Remarks on result:

other: Mean Draize score at 28 hours 2.8/110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Score:

0.4

Reversibility:

fully reversible

Remarks on result:

other: Mean Draize score at 48 hours 0.4/110.

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Mild redness at 24 hours post instillation in 4 rabbits. Minimal redness in 1 rabbit at 48 hours.

Other effects:

OTHER EFFECTS: One animal died, cause unreported. The remaining animals were scored.

Result:         

 AVERAGE SCORE (24+48+72 hour)

                 - Cornea: 0

                 - Iris: 0

                 - Conjunctivae (Redness, chemosis, discharge): scored togetherusing the Draize calculation individual scores 4, 4, 2, 4, 0 at 24 hours and 0, 0, 0, 0, 2 at 48 hours.

                 - Overall score: Mean Draize score at 28 hours 2.8/110, at 48   hours 0.4/110.

 

                 DESCRIPTION OF LESIONS:

Mild redness at 24 hours post  instillation in 4 rabbits. Minimal redness in 1 rabbit at 48     hours.

 

                REVERSIBILITY: All scores 0 by 72 hours and remaining 0 at day 7.

 

               OTHER EFFECTS: One animal died, cause unreported. The remaining animals were scored.

 

 

Interpretation of results:

other: not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Result: not irritating . Based on the Draize scores reported it is considered that Alcohols, C16-18 is not not an eye irritant according to either EU or GHS criteria.The alcohols with chain lengths of C16-18 are non-irritant to eye.

Executive summary:

Result: not irritating . Based on the Draize scores reported it is considered that Alcohols, C16-18 is not not an eye irritant according to either EU or GHS criteria.The alcohols with chain lengths of C16-18 are non-irritant to eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Eye irritation

 

-The acute eye irritation study (Carter, G., Dharmarajan, V., and Weill, H. .1975) indicates that Alcohols, C16-18wasnot irritating.

Result: not irritating. Based on the Draize scores reported it is considered that Alcohols, C16-18 is not not an eye irritant according to either EU or GHS criteria.The alcohols with chain lengths of C16-18 are non-irritant to eye.

The study (Continental Oil Company,Hayes Consultancy Service Bromley, Kent,1979), . indicates that Alcohols, C16-18wasnot eye irritating.

Result: not irritating

 Based on the Draize scores reported it is considered that Alcohols, C16-18 is not not an eye irritant according to either EU or GHS criteria.The alcohols with chain lengths of C16-18 are non-irritant to eye.

Based on the descriptions of the lesions it is considered that Alcohols, C16-18 is not irritating to eye according to EU criteria or GHS criteria.

  

 Skin irritation

Linear Alcohols.The data demonstrate that lower members of the linear alcohols (C6 – C11) have a skin irritancy potential ranging from mild to irritant, when applied undiluted for 4 – 24 hours. Application of diluted materials resulted in a lower grade irritation. The skin irritation potential of linear alcohols in the range C12 and C16 is graded as mild - essentially non-irritant. Alcohols with a carbon chain length C18 and above were generally without evidence of a skin irritation potential.

Conclusion:Aliphatic alcohols in the range C6 – C11 are mild irritants, not anticipated to be corrosive. Aliphatic alcohols in the range C12 – C16 have a low degree of skin irritation potential; alcohols with chain lengths of C18 and above are non-irritant to skin.

The results of the study (Carter, G., Dharmarajan, V., and Weill, H. 1975) indicate that Alcohols, C16-18is non-irritant to skin. Following a 24 hour semi-occlusive exposure to rabbit skin Alcohols, C16-18 is classified as non-irritant based on either EU or GHS criteria. The alcohols with chain lengths of C16-18 are non-irritant to skin.

The results of the study (Continental Oil Company,Hayes Consultancy Service Bromley, Kent,1979) indicate that Alcohols, C16-18is non-irritant to skin.

 Based on the descriptions of the lesions it is considered that Alcohols, C16-18 is not irritatingto skin according to EU criteria or GHS criteria.

 

 

Respiratory irritation.

There is no information available from single or repeated inhalation exposures in laboratory animals or from human experience allowing a conclusion on potential respiratory tract irritation of the aliphatic alcohols.

 

Justification for classification or non-classification

Based on the hazard assessment of  Alcohols, C16-18 in section 2.1 and 2.2. in IUCLID 5.4., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99)and according to the criteria described in Directive 67/548 and in the CLP Regulation:

 

Directive 67/548

Skin Corrosivity C R35 Causes severe burns R34 Causes burns Skin Irritation Xi R38 Irritating to skin R43 May cause sensitization by skin contact Eye Irritation (Ocular Lesions) Xi R36 Irritating to eyes R37 irritating to respiratory system R41 Risk of serious damage to eyes

CLP

Skin Corrosivity  H314 Skin Corr 1A Causes severe skin burns and eye damage H314 Skin Corr 1B Causes severe skin burns and eye damage Skin Irritation  H315 Skin Irrit. 2 Causes skin irritation H317 Skin Sens. 1 May cause an allergic skin reaction Eye Irritation (Ocular Lesions) Xi H319 Eye Irrit. 2 Causes serious eye irritation H318 Eye Dam. 1 Causes serious eye damage H335 STOT SE 3 May cause respiratory irritation

 

It is concluded that the substance  Alcohols, C16-18 does not meet the criteria to be classified for human health hazards for Dermal-local effect.

  

It is concluded that the substanceAlcohols, C16-18 does not meet the criteria to be classified for human health hazards forrespiratory irritation