Glycerides, C18-36

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(Limited details on materials and methods, and results, no test substance volume.)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Limited information on materials and methods, males only were dosed, no individual animal data, no necropsy, limited observation period.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted Feb 1987

Deviations:

yes

Remarks:

Limited information on materials and methods, mouse species, limited observation period, males only were dosed, no individual animal data, no necropsy.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

mouse

Strain:

other: SPF NMRI

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 19 - 20 g

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: the animals were observed for mortality and morbidity, and the body weight was recorded; the frequency was not reported
- Necropsy of survivors performed: no

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the study period.

Clinical signs:

No adverse clinical signs were reported.

Body weight:

The body weight growth was reported to be "normal".

Interpretation of results:

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

Conclusions:

The observation period was only 6 days. However, as no clinical signs were observed and the body weight development was described to be normal, it is unlikely that mortality would have occurred in the time period Day 7-14. The study is therefore considered to be sufficient to meet the data requirement and the LD50 is considered to be > 2000 mg/kg bw.

Cross-reference 2

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(Limited details on materials and methods, no anaesthetics were used, unknown test substance volume.)

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adpoted Oct 2012

Deviations:

yes

Remarks:

Limited details on materials and methods, test substance volume, no anaesthetics were used.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 (sex not specified)

Details on study design:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

cornea opacity score

Basis:

other: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

other: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

other: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

At the 1-h reading time point, 3/3 rabbits exhibited moderate to severe conjunctivae (score 2-3). 3/3 animals had mild-moderate conjunctivae (score 1-2) at the 24-h reading time point (the score was reduced in 2/3 animals at this time point). The conjunctivae persisted in 1/3 animals until 48 h after treatment, while the effect had cleared in the remaining 2/3 animals. All signs of conjunctivae were reversed within 72 h after treatment. 2/3 animals showed chemosis at the 1-h reading time point; the chemosis had cleared completely within 24 h after treatment. No effects were repoted on the cornea or iris in any animal at any reading time point.

Table 1. Individual eye irritation scores

Rabbit #	Time	conjunctivae		iris	cornea
		redness	swelling
1	1 h	2	0	0	0
	24 h	2	0	0	0
	48 h	1	0	0	0
	72 h	0	0	0	0
	Average*	1.0	0.0	0.0	0.0
2	1 h	2	1	1	0
	24 h	1	0	0	0
	48 h	0	0	0	0
	72 h	0	0	0	0
	Average*	0.33	0.0	0.0	0.0
3	1 h	3	1	0	0
	24 h	2	0	0	0
	48 h	0	0	0	0
	72 h	0	0	0	0
	Average*	0.67	0.0	0.0	0.0

*(24h+48h+72h)/3

 

 

Interpretation of results:

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

Conclusions:

The test substance volume was not stated in the study report. However, the study report states that the test was performed according to OECD guideline 405, which specifies that a volume of 0.1 mL should be used. The result of the study is therefore considered to be acceptable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted Jul 2015

Deviations:

yes

Remarks:

Limited details on materials and methods, and results; no test substance volume.

GLP compliance:

no

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Observation period:

72 h

Number of animals:

3 (sex not specified)

Details on study design:

OBSERVATION TIME POINTS
1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

3/3 animals showed mild erythema (score 1) at the 1-h reading time point, which persisted in 1/3 animals until the 24-h reading time point. All effects had cleared within 48 h after patch removal. No oedema was observed in any animal at any time point.

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:

The test substance volume was not stated in the study report. However, the study report states that the test was performed according to OECD guideline 404, which specifies that a volume of 0.5 mL should be used. The result of the study is therefore considered to be acceptable.