Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters

Endpoint summary

Description of key information

The skin irritation test was performed by means of a single dose application of the test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)], C12-13-branched alkyl esters on the skin of 6 albino male rabbits according to OECD Guideline 404.

The test material was applied to the skin of 6 rabbits at a dose of 500 mg for 4 hours. The animals were observed after the removal of the bandages and after 24, 48 and 72 hours for signs of erythema or oedema. During the study a slight erythema was observed, this erythema disappeared after 72 hours.

Under the test conditions the test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)], C12-13-branched alkyl esters can be considered non-irritant for the skin according to GHS criteria.

An ocular irritation test was carried out on test material Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters according to OECD Guideline 405. The test was performed by placing the test material in a single dose in the conjunctival sac of 6 albino male rabbits at a dose of 0.1 mL/animal. The animals eyes were examined 1, 24, 48 and 72 hours after the beginning of the test by means of a binocular loupe. The ocular areas observed were the cornea, the iris and conjunctivae. The results showed a slight congestion of the conjunctivae in all rabbits treated after 60 minutes, still in 4 animals after 24 hours, in 2 animals after 48 hours. The irritation disappeared 72 hours after treament in all animals.

It was concluded that Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters is to be considered non-irritant to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Padre Antonio - Mariano Comense (CO)
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: singly in stainless steel cages (dimensions: 450x500x380 mm) equipped with automatic washing cycle
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum by the authorized breeder RIEPER
- Water (e.g. ad libitum): filtered tap water from local network ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
Temperature and humidity were regulated by a conditioning plant and were continuously recorded, no further details mentioned
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10-March-1992 To: 17-March-1992

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: non-treated area of the skin; each animal served as its own control, the non-treated area is on the left side of the back

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg

EXPERIMENTAL DESIGN
Each animal served as its own control, having a treated and a non-treated area, the first on the right side and the latter on the left side of its back.

Duration of treatment / exposure:

4 h

Observation period:

after 60 min, 24, 48 and 72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: approx. 20 cm² on the right flank
- % coverage: no data
- Type of wrap if used: the sample was placed under a pad, which was kept in place by means of thin bands of adhesive hypoallergenic tape (Blenderm 3M), wrapped with rubberized cloth (Acrylastic Beyersdorf AG Hamburg)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with a pad soaked in distlilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to guideline

Skin preparation:
Approximately 24 hours before the test fur was removed from an area approximateky 240 cm2 wide by clipping and shaving the dorsal and flank zones of the animals. An area of about 20 cm2 on the right flank was used for the application of the assay sample. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used.

Administration:
Square gauze pads 2.5 cm x 2.5 cm fixed to adhesive tape (Hansamed strips) were used. 0.5 g of the assay sample were placed under the pad, which was kept in place by means of thin bands of adhesive hypoallergenic tape (Blenderm 3M). The entire trunk of the animal was then wrapped with rubberized cloth (Acrylastic Beyersdorf AG Hamburg).

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 60 minutes

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 60 minutes

Score:

1

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0.67

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0.57

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0.33

Max. score:

4

Irritant / corrosive response data:

see table below

Other effects:

none

Table: 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	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	1/1/1/1/1/1	0/0/0/0/0/0
24 h	0/1/1/0/1/1	0/0/0/0/0/0
48 h	0/1/1/0/0/1	0/0/0/0/0/0
72 h	0/1/1/0/0/0	0/0/0/0/0/0
5 d	0/0/0/0/0/0	0/0/0/0/0/0
Reversibility*)	yes	-

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions the test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)], C12-13-branched alkyl esters can be considered as non-irritant.

Executive summary:

The test was performed by means of a single dose application of the test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)], C12-13-branched alkyl esters on the skin of 6 albino male rabbits according to OECD Guideline 404.

The test material was applied to the skin of 6 rabbits at a dose of 500 mg for 4 hours. The animals were observed after the removal of the bandages and after 24, 48 and 72 hours for signs of erythema or oedema. During the study a slight erythema was observed, this erythema disappeared after 72 hours.

Under the test conditions the test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)], C12-13-branched alkyl esters can be considered non-irritant for the skin accoriding to GHS criteria.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Padre Antonio - Mariano Comense (CO), Italy
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: singly in stainless steel cages (dimensions: 450x500x380 mm)
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum by the authorized breeder Rieper
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
Temperature and humidity were regulated by a conditioning plant and were continuously recorded, no further details mentioned
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02-JUN-1992 To: 05-JUN-1992

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated left eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

at 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

6

Details on study design:

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

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: binocular loupe

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

other: 60 min

Score:

1.33

Max. score:

3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24 h

Score:

0.67

Max. score:

3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

48 h

Score:

0.33

Max. score:

3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

for details see table below

Table: 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	0/0/0/0/0/0	2/1/1/2/1/1	0/0/0/0/0/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0	1/0/0/1/1/1	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0	1/0/0/1/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0	0	0.33	0
Reversibility*)	-	-	c.	-
Average time for reversion	-	-	72 h	-

 

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

 

Interpretation of results:

GHS criteria not met

Conclusions:

The test material Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters was not an eye irritant.

Executive summary:

An ocular irritation test was carried out on test material Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters according to OECD Guideline 405.

The test was performed by placing the test material in a single dose in the conjunctival sac of 6 albino male rabbits at a dose of 0.1 mL/animal. The animals eyes were examined 1, 24, 48 and 72 hours after the beginning of the test by means of a binocular loupe.

The ocular areas obvserved were the cornea, the iris and conjunctivae. The results showed a slight congestion of the conjunctivae in all rabbits treated after 60 minutes, still in 4 animals after 24 hours, in 2 animals after 48 hours. The irritation disappeared 72 hours after treament in all animals.

It was concluded that Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters is to be considered non-irritant to eyes.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No classification for irritation/corrosion is indicated according to the classification, labeling and packaging (CLP) regulation (EC 1272/2008).