Alcohols, C6-8, ethoxylated

Endpoint summary

Description of key information

In a GLP compliant OECD 404 study for skin irritation / corrosion, the registered substance produced only minor dermal responses which were fully reversible. Based on the results, the substance is considered to be not irritating to skin. With respect to eye irritation, the registered substance when tested in a GLP compliant OECD 405 study exhibited slight to moderate signs of irritation, which was fully reversible within 7 days post exposure. Based on the findings, the test material has to be considered as irritating to eyes.

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:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 -5 month
- Weight at study initiation: 188 - 201 g (male), 167 - 196 g (female)
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per patch
- Concentration (if solution): 100 %

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100%
- Type of wrap if used: semi-occlusive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 4 hour exposure

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.78

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 3 days

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.1

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no edema observed throughout the study

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no edema observed throughout the study

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Other effects:

dry-rough skin, dwsquamation of fine and coarse scales

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Flotanol F was not irritating to rabiit skin and is not subject for labelling requirements

Executive summary:

The primary skin irritation potential of Flotanol F was evaluated according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL of undiluted test material.The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30-60 minutes, 24, 48 and 72 hours as well as 7 and 14 days after removal of the patches. Erythema and oedema were evaluated numerically according to the score of DRAIZE. From 1 hour up to 72 hours after removal of the patches, slight to moderate erythema were observed in all animals. A slight reddening was still observed in one animal at day 7. Except one slight oedema observed in one animal 48 hours after patch removal, no swellings at any of the readings were observed. 14 days pa.a all signs of ittitation were revesible. Based on the study results, Flotanols F is not subject to labelling requirements with regard to skin irritating effects.

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:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL per ey
- Concentration (if solution): 100%

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours post exposure, every reading with fluorescence testing

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein

Irritation parameter:

cornea opacity score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

iris score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no iridial effects observed throughout study period

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

2.66

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Remarks:

overall

Basis:

mean

Remarks:

all animls

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, Flotanol F is considered to be irritating to eyes.

Executive summary:

The primary eye irritation potential of Flotanol F was evaluated in the New Zealand albino rabbit according to OECD test guideline 405. Only animals without ocular abnormalities were used for the study. o.1 mL of undiluted test material was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were examined 1, 24, 48 and 72 hours as well as 7 and 14 days after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. From one hour up to 72 hours after administration the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson color. The effects were accompanied by aqueous eye discharge. Additionally, from one hour up to 72 hours slight scattered or diffuse areas of corneal opacity as well as sporadic iridial effects were noted in some animals. 7 days after application all signs of irritation were reversible. Accordingly, the tested Flotanol F is considered to be an eye irritant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

GLP compliant guideline studies are available for the evaluation of the endpoints skin irritation / corrosion and eye irritation with the pure registered substance. With regard to skin irritation / corrosion, three New Zealand albino rabbits were exposed to 0.5 mL of undiluted test material for 4 hours under semi-occlusive test conditions in accordance with OECD guideline 404. Skin reactions were assessed 30 -60 minutes, 24, 48 and 72 hours as well as 7 and 14 days after removal of the patches. As a result slight to moderate erythema were observed in all animals up to 72 hours. However, except one slight oedema in one animal at the 48 hour reading, no swellings were observed. 14 days p.a. all signs of irritation were reversible.

The primary eye irritation potential of the registered substance was evaluated in the New Zealand albino rabbit according to OECD test guideline 405. Only animals without ocular abnormalities were used for the study. o.1 mL of undiluted test material was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The exposure period was 24 hours. The eyes were examined 1, 24, 48 and 72 hours as well as 7 and 14 days after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. From one hour up to 72 hours after administration the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson color. The effects were accompanied by aqueous eye discharge. Additionally, from one hour up to 72 hours slight scattered or diffuse areas of corneal opacity as well as sporadic iridial effects were noted in some animals. 7 days after application all signs of irritation were reversible. Based on the study results, the registered substance is considered to be an eye irritant.

Justification for selection of skin irritation / corrosion endpoint:
Guideline study according to GLP with a Klimisch rating 1

Justification for selection of eye irritation endpoint:
Guideline study according to GLP with a Klimisch rating 1

Effects on eye irritation: irritating

Justification for classification or non-classification

In a guideline and GLP compliant primary skin irritation/corrosion study, the registered substance produced only slight to moderate skin responses. Based on the individual mean scores for erythema and oedema no classification of the registered substance with regard to skin irritation/corrosion is warranted, neither according to the EU Dangerous Substances Directive 67/548 (DSD) nor according to the criteria of the EU Classification, Labelling and Packaging Regulation 1272/2008/EC (CLP).

With regard to primary eye irritation, a guideline and GLP compliant study revealed individual mean scores for conjunctivae which are supportive of classifying the registered substance as `R36 - irritating to eyes` according to the criteria of the EU DSD and as `category 2`with `H319 - causes serious eye irritation`.