Potassium isooctadecanoate

Endpoint summary

Description of key information

According to Annex I of Regulation (EC) 1272/2008, the test item  has no obligatory labelling requirement for skin irritation.

According to Annex I of Regulation (EC) 1272/2008, the test item  has no obligatory labelling requirement for eye irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The source study was conducted with isooctadecanoic acid. The read across source substance is considered a structural analogue taking into account the physico-chemical properties (surface active properties, logKow, water solubility) and the chemical structure of the test item (potassium soap of isooctadecanoic acid). Besides published data on skin irritation properties of long chain fatty acids and their salts are considered relevant for this read across approach. The results of the source substance are considered relevant for human health endpoints skin irritation, eye irritation and consecutive risk assessment of local effects. See read across document for further details.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Name of test material (as cited in study report): Prisorine 3505 Acide Isostearique
Physical state: liquid
Analytical purity: no data
Other: light yellow

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

other: untreated sites of the same animal served as control

Duration of treatment / exposure:

4 hours

Observation period:

1, 5 hours after removal of the dressing and 24, 48, 72 hours and 7 days after application

Number of animals:

3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Other effects:

Slight reactional dryness together with decrease in skin suppleness were also observed. Clear irritative phenomena were observed. They remained during 24 hours without any changes, and then decreased regularly. On day 6, not any irritation was seen, but slight changes in skin structure persisted until day 10.

Interpretation of results:

GHS criteria not met

Conclusions:

According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for skin irritation.

Executive summary:

Under the conditions of the present OECD 404 study, a single application of the test item to rabbits produced irritant effects, which were fully reversible within 6 days in all animals. Neither mortalities nor significant clinical signs of toxicity were observed. According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for skin irritation.

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:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The source study was conducted with isooctadecanoic acid. The read across source substance is considered a structural analogue taking into account the physico-chemical properties (surface active properties, logKow, water solubility) and the chemical structure of the test item (potassium soap of isooctadecanoic acid). Besides published data on eye irritation properties of long chain fatty acids and their salts are considered relevant for this read across approach. The results of the source substance are considered relevant for human health endpoints skin irritation, eye irritation and consecutive risk assessment of local effects. See read across document for further details.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Name of test material (as cited in study report): Prisorine 3505 Acide Isostearique
Physical state: liquid
Analytical purity: no data
Storage condition of test material: at room temperature
Other: light yellow

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test animals
Source: Elevage des Feuilletas
Weight at study initiation: 2 ± 0.2 kg
Housing: individually housed in stainless steel cages (61x46x34 cm) with a grid floor
Diet (ad libitum): UAR 112
Water (ad libitum): tap water
Acclimation period: 4 days

Environmental conditions
Temperature (°C): 22 ± 5
Humidity (%): 55 ± 25
Air changes (per hr): 14
Photoperiod (hrs dark / hrs light): 12 per day, in a complementary way with natural and artificial lighting

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

other: the untreated eye served as control

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

72 h. Reading time points: 1, 24, 48, 72 h

Details on study design:

Scoring system: Draize score

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2, 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: #1, 2, 3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

chemosis score

Basis:

animal: #1, 2, 3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 h reading

Irritation parameter:

conjunctivae score

Basis:

animal: at 24 h reading

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h reading

Irritant / corrosive response data:

A slight enanthema together with slight chemosis was observed in all 3 animals at the 1 hour reading. Enanthema remained during 48 hours in one animal and only 24 hours in the other two. Not any lesion of iris or cornea was recorded.

The irritative phenomena were minor and not any lesion was seen after 48 hours.

Interpretation of results:

GHS criteria not met

Conclusions:

According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for eye irritation.

Executive summary:

Under the conditions of the present OECD 405 study, a single application of the test item to rabbits produced slight irritant effects, which were fully reversible within 72 hours in all animals. Neither mortalities nor significant clinical signs of toxicity were observed. According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for eye irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available