Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-10-08 to 1992-10-14

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

February 24, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

EC Number:

946-420-6

Molecular formula:

not applicable

IUPAC Name:

Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): ad libitum, Ssniff K-Haltung (Zuchtdiät für Kaninchen), Form: pellets, 1.0-1.5 cm long, 0.5 cm diameter, Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water (e.g. ad libitum): ad libitum, drinking water as for human consumption, System: drinking nipples

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12h light/ 12h dark cycles

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

the eye were not washed after treatment

Observation period (in vivo):

24, 48 and 72 h after treatment and thereafter once daily up to days 5-6 post application

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed


SCORING SYSTEM: According to OECD Test Guideline 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 5 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritant / corrosive response data:

2/3 animals showed ocular secretion after treatment. Iris inflammation was observed in 2/3 animals 1 h after application of the test item. In all animals, conjunctival redness and chemosis were observed up to day 2-5 after application of the test item.

Other effects:

no other effects observed

Any other information on results incl. tables

Table 1: 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 Max. score: 4	Iris Max. score: 2	Conjunctivae Max. score: 3	Chemosis Max. score: 4
60 min	0/0/0	1/1/0	1/1/2	2/1/1
24 h	0/0/0	0/0/0	2/1/2	2/1/1
48 h	0/0/0	0/0/0	2/1/2	2/1/1
72 h	0/0/0	0/0/0	1/0/1	1/0/1
Average 24h, 48h, 72h	0/0/0	0/0/0	1.67/0.67/1.67	1.67/0.67/1
Reversibility*)	c	c	c	c
4 d	0/0/0	0/0/0	1/0/1	0/0/0
5 d	0/0/0	0/0/0	1/0/0	100/0
6 d	0/#/#	0/#/#	0/#/#	0/#/#

 

# In animals 2 and 3 the test was terminated after examination on day 5

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, Polyglycerin caprinate was not irritating to the eye.

Executive summary:

In a primary eye irritation study according to OECD guideline 405 (February 24, 1987) 0.1 mL of polyglycerin caprinate (>95% a.i.) was instilled into the conjunctival sac of the left eye of 3 New Zealand White rabbits, the untreated right eye of each animal served as control. The were not rinsed after treatment. The animals were observed for clinical signs of eye irritation and inflammation at 1 h after instillation and after 24, 48 and 72h, thereafter the animals were examined once daily up to day 5 -6. Two animals (no. 1 and 3) showed ocular secretion after treatment. Iris inflammation was observed in animal no. 1 and 2, 1 h p.a. In all animals signs of redness and chemosis of the conjunctivae were observed up to 2-5 days p.a. All detected effects were reversible within 6 days p.a. Thus, the test item is considered to be not irritating to the eye according to GHS criteria.