isostearic acid monoisopropanolamide

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source: "l'elevage Cunicole de Val de Seile, 80160 Prouzel, France"
Acclimation: at least 5 days
Weight: 2.6 +/- 0.2 kg
Temperature: 20 +/- 3°C
Relative humidity: 50 +/- 20%
Light period: 12h light / 12h dark
Feed: "Lapins entretien reference 112 C" (U.A.R., 91360 Villemoisson-Sur-Orge, France), ad libitum
Water: filtered tap water, ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL in the conjunctival sac of the left eye

Duration of treatment / exposure:

One application

Observation period (in vivo):

1, 24, 48 and 72h

Number of animals or in vitro replicates:

3

Details on study design:

Eye reactions were evaluated and scored (0 - 4) for chemosis (lids), eye watering and redness (conjunctive tissues, cornea and iris).

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: after 1 h

Score:

>= 0 - <= 2

Max. score:

3

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: chemosis, enanthema and redness

Irritation parameter:

other: eye watering

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 24 h

Remarks on result:

not determinable

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Some slight conjunctival reactions (chemosis with a score < or = to 1, enanthema with a score of 1 to 2, and redness with a score of < or = to 1.3) were observed in the 3 rabbits after 1h. Neither iris irritation nor corneal opacity were recorded. Reactions were fully reversible; no effects were seen at 24, 48 and 72h.

None.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the test substance was not considered to be irritating to rabbit eye.

Executive summary:

A study was conducted to determine the eye irritation potential of the test substance, isoC18 MIPA (purity not specified), according to EU Method B.5, in compliance with GLP. Three male rabbits (New-Zealand White) received 0.1 mL of the undiluted test substance in the conjunctival sac of the left eye. The right eye remained untreated and served as control. Observations were made at 1, 24, 48 and 72 h. Eye reactions were evaluated and scored (0 - 4) for chemosis (lids), eye watering and redness (conjunctive tissues, cornea and iris). Some slight conjunctival reactions (chemosis with a score of ≤ 1 and enanthema with a score of 1 to 2) were observed in the 3 rabbits after 1 h. Neither iris irritation nor corneal opacity were recorded. Reactions were fully reversible; no effects were seen at 24, 48 and 72 h. Under the study conditions, the test substance was not considered to be irritating to rabbit eye (Clouzeau, 1992).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

A study was conducted to determine the skin irritation / corrosion potential of the test substance, isoC18 MIPA (purity not specified), according to EU Method B.4, in compliance with GLP. Three male rabbits (New Zealand White) were exposed for 4 h to 0.5 mL undiluted test substance, under a semiocclusive bandage. The left flank remained untreated and served as control. Observations were made at 1, 24, 48 and 72 h and daily thereafter (for 9 d). Skin reactions (erythema and oedema) were evaluated using the Draize scoring and measured after 24, 48 and 72 h. Significant skin reactions were observed for at least 48 h in the 3 animals. These erythema reactions persisted for 72 h after treatment (mean scores of 1.7, 2.0 and 2.0 in each animal). No oedema was observed. From Day 5, the erythema decreased and disappeared on Day 8. A darkness of the skin persisted until Day 8. Under the study conditions, the test substance was considered to be irritating to rabbit skin but not sufficiently to trigger classification according to CLP (EC 1272/2008) criteria (Clouzeau, 1992).

Eyes

A study was conducted to determine the eye irritation potential of the test substance, isoC18 MIPA (purity not specified), according to EU Method B.5, in compliance with GLP. Three male rabbits (New-Zealand White) received 0.1 mL of the undiluted test substance in the conjunctival sac of the left eye. The right eye remained untreated and served as control. Observations were made at 1, 24, 48 and 72 h. Eye reactions were evaluated and scored (0 - 4) for chemosis (lids), eye watering and redness (conjunctive tissues, cornea and iris). Some slight conjunctival reactions (chemosis with a score of ≤ 1 and enanthema with a score of 1 to 2) were observed in the 3 rabbits after 1 h. Neither iris irritation nor corneal opacity were recorded. Reactions were fully reversible; no effects were seen at 24, 48 and 72 h. Under the study conditions, the test substance was not considered to be irritating to rabbit eye (Clouzeau, 1992).

Justification for classification or non-classification

Skin

Based on the results of an in vivo study, classification for skin irritation as XXXX is warranted for the test substance according to CLP (EC 1272/2008) criteria.

Eye

Based on the results of an in vivo study, no classification for eye irritation is required for the test substance according to CLP (EC 1272/2008) criteria.