Fatty acids, C16-18, 2-butyloctyl esters

Endpoint summary

Description of key information

not skin irritating
not eye 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:

2005-02-15 - 2005-02-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP-study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: Little Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River GmbH, 97633 Sulzfeld
- Age at study initiation: approx. 13 to 17 months
- Weight at study initiation: 2.4 - 2.6 kg b.w.
- Housing: The study took place in animal room No. 6 and 8 provided with filtered air. During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 sq. cm) with perforated floor.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet "Altromin 2123" from Altromin, 0-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet.
- Water (e.g. ad libitum): The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants are performed regularly.
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: not mentioned

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated area on the test animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL, test substance was applied to the 16-layer gauze patch (2.5 x 2.5 cm) and the test patch was secured to the animals skin with adhesive Gothaplast tape (2.5 cm) (semiocclusive)

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: rabbit back (2.5 cm x 2.5 cm)
- % coverage: no data
- Type of wrap if used: test patch: Gothaplast tape (2.5 cm and 5 cm wide)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; with mild soap and lukewarm water
- Time after start of exposure: 3 min, 1 h, 4 h (3 different exposure times)

SCORING SYSTEM: according to table in OECD TG 404 (Draize system)

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 0, 1, 24, 48, and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 0, 1, 24, 48, and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Irritant / corrosive response data:

no effects

Other effects:

no effects

Skin reactions following a single topical application of 0.5 mL of Isofol ester 1202 to rabbits (grading according to OECD TG 404)

 

None of the animals showed an edema reaction or erythema.

 

Animal	Skin reaction	1 h afterpatch removal	24 h  afterpatch removal	48 h  afterpatch removal	72 h  after patch removal	Mean (24 -72 h) after patch removal
1	Erythema	0	0	0	0	-
	Edema	0	0	0	0	-
2	Erythema	0	0	0	0	-
	Edema	0	0	0	0	-
3	Erythema	0	0	0	0	-
	Edema	0	0	0	0	-

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of the study described in this report and according to the directive of the EEC commission 2001/59/EC from August 6th, 2001 the test substance was not skin irritating and shall not be classified as skin irritating.

Executive summary:

During an initial test using one female albino rabbit a sequential application (exposure time 3 min., 1 h. and 4 h.) of the test substance was carried out on one site of the right back area each. The skin was examined for signs of irritation straight after as well as 1 h., 24 h., 48 h. and 72 h. after the termination of exposure. Since the animal did not show signs of skin irritation and no full thickness destruction of the skin within the observation period of 72 hours it was decided to carry out a confirmatory test with two additional animals in order to allow a categorization of the test item based on the classification criteria.Two female albino rabbits were exposed to the test item at one skin site on the back during the confirmatory test. After 4-hour exposure time the test item was removed and the skin was examined 1 h., 24 h., 48 h. and 72 h after the termination of exposure. No skin reactions were observed in these animals, too. Under the experimental conditions described in this final report, the mean score for erythema was 0.0 and for oedema 0.0. Based on the results of the study described in this report and according to the directive of the EEC commission 2001/59/EC from August 6th, 2001 the test substance was not skin irritating and shall not be classified as skin irritating.

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:

2005-02-15 until 2005-02-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: Little Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River GmbH, 97633 Sulzfeld
- Age at study initiation: approx. 7 to 10 months
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: The study took place in animal rooms No. 5 and 8 provided with filtered air at a temperature of 20°C ± 3°C, relative humidity of 55 % ± 15 % and air changes 10 times/ hour. The room was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 6 am to 6 pm.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet "Altromin 2123" from Altromin, 0-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet.
- Water (e.g. ad libitum): The animals had free access to bottles with domestic quality drinking water acidified
with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants are performed regularly.
- Acclimation period: at least 1 week, throughout the study the rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55 % ± 15 %
- Air changes (per hr): 10 times/ hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the test animal

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): irrigation with 20 ml 0.9 % sodium chloride solution
- Time after start of exposure: 24 h

SCORING SYSTEM:
Cornea:
Opacity: degree of density (readings should be taken frommost dense area):
Score 0: no ulceration or opacity
Score 1: scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible
Score 2:easily discernible translucent area; details of iris slightly obscured
Score 3: nacrous area; no details of iris visible; size of pupil barely discernible
Score 4: opaque cornea, iris is not dicernible through the opacity

Area of the cornea involved:
Score 1: One quarter (or less) but not zero.
Score 2:More than one quarter. but less than half.
Score 3: More than half, but less than three quarters.
Score 4: More than three quarters, up to whole area.

Iris:
Score 0: normal
Score 1: markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (sluggish reaction is considered to be an effect)
Score 2: hemorrhage, gross destruction, or no reaction to light

Conjunctiva: Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Score 0:normal
Score 1: some blood vessels hyperaemic (injected)
Score 2:diffuse, crimson colour; individual vessels not easily discernible
Score 3: diffuse beefy red

Chemosis: swelling (refers to lids and/or nictating membranes)
Score 0: normal
Score 1: sorne swelling above normal
Score 2: obvious swelling, with partial eversion of lids
Score 3: swelling, with lids about half closed
Score 4: swelling, with lids more than half closed

TOOL USED TO ASSESS SCORE: fluorescein, UV light

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0

Max. score:

2

Remarks on result:

other: no effects observed

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 24, 48, and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48, and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Eye irritating effects following a single instillation of 0.1 mL of Isofol Ester 1202 to rabbit eyes (grading according to OECD TG 405)

 

Animal	Effect	Score (time after application)
		1 h	24 h	48 h	72h	Mean	F
1	Cornea	1 (degree) 2 (area)	0 0	0 0	0	0	-
	Iris	0	0	0	0	0	-
	Conjunctivae Redness	1	1	0	0	0.33	-
	Chemosis	0	0	0	0	0	-
2	Cornea	0	0	0	0	0	-
	Iris	0	0	0	0	0	-
	Conjunctiva Redness	1	1	0	0	0.33	-
	Chemosis	0	0	0	0	0	-
3	Cornea	0	0	0	0	0	-
	Iris	0	0	0	0	0	-
	Conjunctivae Redness	1	1	0	0	0.33	-
	Chemosis	0	0	0	0	0	-

 

 

In general, the irritating effect of Isofol Ester 1202 on the rabbit eye was weak.

 

 

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of the study described in the report and according to the directive of the EEC commission 2001/59/EC from August 6th, 2001 the test substance shall not be classified as eye irritating.

Executive summary:

In a OECD 405 study, 0.1 mL of the test substance was instilled into the conjunctival sac of one eye of each of 3 Little Russian rabbits for 24 hours. Eyes were washed with 20 ml 0.9 % sodium chloride solution at the end of the exposure period. Eye irritation was scored 1 h, 24 h, 48 h, 72 h after instillation of the test substance using the grading system of OECD test guideline 405 (Acute Eye Irritation/Corrosion).

One hour after the application of the test item animal No. 2928 showed scattered or diffuse opacity quarter the area of the cornea of the cornea on more than one quarter. Additionally some hyperaemic, conjunctival blood vessels were observed. Animals No. 3164 and No. 3163 showed some hyperaemic, conjunctival blood vessels only. 24 h. after the application of the test item animals No. 2928, No. 3164 and No. 3165 showed some hyperaemic, conjunctival blood vessels. 48 and 72 h. after the application of the test item animals No. 2928, No. 3164 and No. 3163 were free of any signs of eye irritation.

 

In this study, the test substance is not irritating to the eye according to EU regulations.

 

This study is assessed as acceptable. It satisfies the guideline requirements (OECD TG 405) for an acute eye irritation/corrosion study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Based on the results of the skin irritation study according to OECD 404 the target substance was not skin irritating and shall not be classified as skin irritating. This result is supported by a human patch test, in which no skin irritation effects were observed in any of the subjects after 48 hours exposure.

In an eye irritation study according to OECD 405 the target substance is not irritating to the eye according to EU regulations.

 

Justification for selection of skin irritation / corrosion endpoint:
There is only one study available for the target substance.

Justification for selection of eye irritation endpoint:
There is only one study available for the target substance.

Justification for classification or non-classification

The target substance was neither skin nor eye irritating and therefore does not require classification according to EU regulations (Directive 67/548/EEC and Regulation (EC) No 1272/2008.