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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was condcuted according to OECD TG 404, EPA TG OPPTS 870.2500 and in accordance with the Principles of Good Laboratory Practice (GLP).
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butoxyethyl benzoate
EC Number:
226-685-8
EC Name:
2-butoxyethyl benzoate
Cas Number:
5451-76-3
Molecular formula:
C13H18O3
IUPAC Name:
2-butoxyethyl benzoate
Test material form:
other: variable colured liquid
Details on test material:
- Name of test material (as cited in study report): Butyl Cellosolve™ Benzoate
- Physical state: variable coloured liquid
- Analytical purity: 99.86%
- Lot/batch No.: 02112012-JLT
- Expiration date of the lot/batch: 11 February 2013
- Storage condition of test material: Ambient (+18 to +36 ºC)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: inhouse bred (outbred)
- Age at study initiation: 7-8 months
- Weight at study initiation: 2.71 - 2.91 kg
- Housing: individually housed in rabbit cages (approx. size: L 65 x B 65 xH 45 cm) under standard laboaratory conditions
- Diet (ad libitum): The animals were offered rabbit feed manufactured by Pranav Agro Industries Ltd, Sangli, Maharashtra, India.
- Water (ad libitum): The animals were provided deep bore-well water passed through activated charcoal
filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier. The water was replenished once daily and the water bottles changed once a week.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23°C
- Humidity (%): 64-67%
- Air changes (per hr): 12-15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hour light and 12 hour dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.5 mL of the undiluted test substance was applied on to the test site of approximately 6 cm2 (2 x 3 cm) and covered by a 6-ply gauze pad. The entire trunk of each animal was then wrapped with non-irritating semi-occlusive adhesive tape to avoid dislocation of the patch.
Duration of treatment / exposure:
4-hour exposure period
Observation period:
7 days
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: Approximately 24 hours before treatment, the fur on the left side of the dorsolateral trunk surface [about 14 x 19 cm] was clipped with an electric clipper -Aesculap®- Germany. Care was taken to avoid abrading the skin. After clipping and prior to application, the animal’s skin (test site) was checked for any abnormalities according to the “Primary Skin Irritation Scoring System”, and the test site was found to be normal.
- % coverage: An approximately 6 cm2 intact test site was selected on each animal. The adjacent untreated skin of each animal served as the control site.
- Type of wrap if used: A volume of 0.5 mL of the undiluted test substance was applied on to the test site of approximately 6 cm2 (2 x 3 cm) and covered by a 6-ply gauze pad. The entire trunk of each animal was then wrapped with non-irritating semi-occlusive adhesive tape to avoid dislocation of the patch.
- The rabbits were restrained using an Elizabethan collar for 4 hours during the contact period of test substance.

REMOVAL OF TEST SUBSTANCE
- Washing: Following the exposure period, test patches were removed and the test sites were washed with de-ionised water to remove any residual test substance.

SCORING SYSTEM: The test sites were examined for signs of erythema and edema within 60 minutes and at intervals of approximately 24, 48 and 72 hours and on Day 7 after test patch removal according to the "Primary Skin Irritation Scoring System" developed by Draize, et.al (1944).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all animals
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all animals
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Erythema score of 1 was observed in two rabbits (RB9663 & RB 9664) at 24, 48 and 72 hours post removal of the test patch. Erythema and Edema score of 1 was observed in the third rabbit (RB9665) at 24, 48 and 72 hours post removal of the test patch. The skin at the treated site of all the three rabbits was normal on the 7th day post removal of the test patch
Other effects:
There were no clinical signs of toxicity or mortality observed during the course of the study and the body weights of all the rabbits increased throughout the observation period.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the testing conditions of this study, 2-butoxyethyl benzoate caused erythema (score of 1) in 3 rabbits and edema (score of 1) in one rabbit and these scores were completely reversed by day 7 post removal of the test patch and according to Guidance to regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, 2-butoxyethyl benzoate will be not classified for skin irritation.
Executive summary:

The acute dermal irritation/corrosion study in rabbits was conducted to evaluate the skin irritation potential of 2-butoxyethyl benzoate. All the three rabbits were treated at the same time (4 hours only) as per sponsor’s request. A volume of 0.5 mL of the undiluted test substance was applied on to the test site of approximately 6 cm2 (2 x 3 cm) and covered by a 6-ply gauze pad. The patch was secured to the body of the animal by a non-irritating semi-occlusive adhesive tape. The patch was removed after 4 hours of skin contact. All test sites were evaluated for skin irritation according to the Draize (1944) evaluation method.

There were no clinical signs of toxicity or mortality observed during the course of the study and the body weights of all the rabbits increased throughout the observation period. Erythema score of 1 was observed in two rabbits (RB9663 & RB 9664) at 24, 48 and 72 hours post removal of the test patch. Erythema and Edema score of 1 was observed in the third rabbit (RB9665) at 24, 48 and 72 hours post removal of the test patch. The skin at the treated site of all the three rabbits was normal on the 7th day post removal of the test patch.

Under the testing conditions of this study, 2-butoxyethyl benzoate caused erythema (score of 1) in 3 rabbits and edema (score of 1) in one rabbit and these scores were completely reversed by day 7 post removal of the test patch and according to Guidance to regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, 2-butoxyethyl benzoate will be not classified for skin irritation.