Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating

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:
2008-12-05 to 2009-02-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 (1 male and 2 females)
Details on study design:
TEST SITE
- Area of exposure: approximately 100 cm² (10 cm x 10 cm)
- Type of wrap if used: The dressing was wrapped around the abdomen and anchored with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure, the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.


SCORING SYSTEM:
Data are summarized in tabular form, showing the irritation scores according to Commission Regulation (EC) No 440/2008 of 30 May 2008 for erythema and oedema for each individual animal at all observation intervals after patch removal, any lesions, a description of the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24hours
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0.67
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining produced by the test item of the treated skin was observed. No alterations of the treated skin were observed and no corrosive effects were evident on the skin.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sorbitan caprylate is considered to be “not irritating” to rabbit skin.
Executive summary:

The primary skin irritation potential of sorbitan caprylate was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours as well as 7 days after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00, 0.67 and 1.00, respectively, and the mean oedema score was 0.00 for all animals.

The application of sorbitan caprylate to the skin resulted in mild signs of irritation (erythema). These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the skin. sorbitan caprylate is considered to be “not irritating” to rabbit 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
Study period:
2008-12-05 to 2009-02-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: COMMISSION REGULATION (EC) No 440/2008 of 30 May 2008, B.5. “Acute Toxicity Eye Irritation/Corrosion”.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
One hour after the treatment, slight reddening of the conjunctivae and the sclerae was noted in all animals. Furthermore, slight swelling (chemosis) of the conjunctiva was observed in the male rabbit and slight discharge was noted in the treated eyes of all animals.
At the 24-hour reading, no abnormal findings were observed in the conjunctivae of the animals; only slight reddening of the sclerae was still noted in one animal. No abnormal findings were observed in the treated eye of any animal 48 hours after the treatment.
No staining produced by the test item of the treated eye was observed.
No corrosion of the cornea was observed at any of the reading times.
Other effects:
No mortality occurred.
No clinical signs were observed during the course of the study.
The body weights of all rabbits were considered to be within the normal range of variability.
No necropsy was performed at the end of the study.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sorbitan caprylate is considered to be “not irritating” to the rabbit eye.
Executive summary:

The primary eye irritation potential of sorbitan caprylate was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. All individual mean scores were 0.00 for all three animals.

The instillation of sorbitan caprylate into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis, which were mostly present at the 1-hour reading. 24 hours after the treatment, no signs of eye irritation were observed in the conjunctivae of the animals. Furthermore, no abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye. Sorbitan caprylate is considered to be “not irritating” to the rabbit eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The primary skin irritation potential of sorbitan caprylate was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three young adult New Zealand White rabbits. The application of sorbitan caprylate to the skin resulted in mild signs of irritation (erythema). These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Thus, sorbitan caprylate does not induce significant or irreversible damage to the rabbit skin.

The primary eye irritation potential of sorbitan caprylate was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. The instillation of sorbitan caprylate into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis, which were mostly present at the 1-hour reading. 24 hours after the treatment, no signs of eye irritation were observed in the conjunctivae of the animals. Furthermore, no abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.

Thus, sorbitan caprylate does not induce significant or irreversible damage to the rabbit eye.

Justification for classification or non-classification

Based on the available data no classification is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).