Branched and linear octadecanoic acid, esters with glycerol oligomers

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Aug - 26 Aug 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

/ no anaesthetics were used, no initial test using one animal was performed, limited data on test animals given (body weight, age)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

02 Oct 2012

Deviations:

yes

Remarks:

/ no anaesthetics were used, no initial test using one animal was performed, limited data on test animals given (body weight, age)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hare-Marland, Hewitt, New Jersey, USA
- Housing: individual, in cages
- Diet: Purina Lab Rabbit Chow, ad libitum
- Water: tap water, ad libitum, anaysis performed
- Acclimation period: at least 5 days

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

IN-LIFE DATES: From: 23 Aug To: 26 Aug 1990

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals (#2, 4 - 6)

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 4 animals (#1, 2, 5, 6)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 2 animals (#3 - #4)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

1 h after test substance application all animals showed conjunctival redness scored with grade 1 which was fully reversible at the 24 h reading time point in all animals except two animals. One male showed a worsening at the 24 h reading time point (score 2), which was augmented at 48 h (score 1) and was reversed at 72 h after application. In the other male the conjunctival redness was fully reversible at 48 h. 1 h and 24 h after test substance application dulling of the cornea was observed in two animals. Additionally, moderate ocular discharge was detected at the 1 h reading time point. In addition, chemosis was observed in all animals 1 h after treatment (grade 1 and 2, respectively) which was reversible in all animals except of two at the 24 h reading time point. For these two animals chemosis was reversible within 48 h (mean score (24, 48, 72 h) = 0.3, respectively). Additionally, moderate ocular discharge was detected at the 1 h reading time point. No effects on iris or cornea were observed.

Any other information on results incl. tables

Table 1: Individual scores of eye irritation

	Rabbit #	Time [h]	conjunctivae		iris	cornea
			redness	chemosis
male	1	1	1	1	0	0
		24	1	0	0	0
		48	0	0	0	0
		72	0	0	0	0
		average	0.3	0.0	0.0	0.0
	2	1	1	2	0	0
		24	0	0	0	0
		48	0	0	0	0
		72	0	0	0	0
		average	0.0	0.0	0.0	0.0
	3	1	1	1	0	0
		24	2	1	0	0
		48	1	0	0	0
		72	0	0	0	0
		average	1.0	0.3	0.0	0.0
female	4	1	1	1	0	0
		24	0	1	0	0
		48	0	0	0	0
		72	0	0	0	0
		average	0.0	0.3	0.0	0.0
	5	1	1	2	0	0
		24	0	0	0	0
		48	0	0	0	0
		72	0	0	0	0
		average	0.0	0.0	0.0	0.0
	6	1	1	1	0	0
		24	0	0	0	0
		48	0	0	0	0
		72	0	0	0	0
		average	0.0	0.0	0.0	0.0

For evaluation, scores obtained at the 24, 48 and 72 h reading time points were considered.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified

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