Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-07-10 to 2000-07-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ZINN(II)-RICINOLEAT

IUPAC Name:

ZINN(II)-RICINOLEAT

Constituent 2

Reference substance name:

Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride

EC Number:

700-814-2

Molecular formula:

not applicable UVCB substance

IUPAC Name:

Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species : Albino Rabbit, New Zealand White, (SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. EC, OECD)
Source : Charles River Deutschland, Kisslegg, Germany.
Number of animals : 3 Animals of one sex.
Age and body weight : Animals used within the study were at least 6 weeks old and body weights were less than 3.5 kg.
Identification : Earmark.
Conditions : A controlled environment was maintained in the room with optimal conditions considered as being approximately 15 air changes per hour, a temperature of 21 DC, a relative humidity of 50% and 12 hours artificial fluorescent light and 12 hours dark per day. Deviations from these optimal conditions were noted, but were considered not to have affected study integrity.
Accommodation : Individually housed in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet : Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, the Netherlands) was provided once a week.
Water : Free access to tap-water. Certificates of quarterly analysis were examined and retained in the NOTOX archives.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

Each animal was treated by instillation of 0.1 ml of the test substance as tile maximum required amount, in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball.

Duration of treatment / exposure:

Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.

Observation period (in vivo):

The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance

Number of animals or in vitro replicates:

3

Details on study design:

A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the eyes, which were free from any abnormality.
Mortality/Viability : Twice daily.
Toxicity : At least once daily.
Body Weight : Day of treatment (prior to instillation).
Irritation : The eyes of each animal were examined approximately 1,24,48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3

Time point:

other: mean 24, 48, 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean 24, 48, 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #2, #3

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Exposure resulted in irritation of the conjunctivae , which was seen as redness, chemosis and discharge. The irritation had completely resolved within 48 hours in one animal and within 72 hours in the other two animals.
No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2 % fluorescein, 24 hours after test substance instillation
revealed no corneal epithelial damage in any of the animals.

Other effects:

Colouration: No staining of peri-ocular tissues by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point/ Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/1/1	0/1/0
24 h	0/0/0	0/0/0	2/1/2	1/0/0
48 h	0/0/0	0/0/0	1/0/1	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0	1/0.33/1	0.33/0/0
Reversibility*)			c.	c.
Average time (unit) for reversion			72 h	72 h

*) Reversibility: c. = completely reversible; n.c.= not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

In this study the test substance is not irritating to the eye. Interpretation is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
According to CLP, EU GHS (Regulation (EC) No 1272/2008) no classification is required for ZINN(II)-RICINOLEAT

Executive summary:

Acute eye irritation/corrosion study with ZINN(II)-RICINOLEAT in the rabbit. The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.5, "Acute Toxicity - Eye irritation" and OECD No 405, "Acute Eye Irritation/Corrosion" .

Single samples of 0.1 ml of ZINN(II)-RICINOLEAT were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substance resulted in irritation of the conjunctivae, which was seen as redness, chemosis and discharge. The irritation had completely resolved within 48 hours in one animal and within 72 hours in the other two animals.

No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2 % fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.

Interpretation of study results is based on mean scores for each animal following grading at 24, 48 and 72 hours for cornea, iris, conjuctiva and chemosis: 

No classification for eye irritation is required for ZINN(II)-RICINOLEAT according to CLP, EU GHS (Regulation (EC) No 1272/2008) and Directive 67/548/EEC.