Butyl glycollate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-JAN-19 through 1988-JAN-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Butyl glycollate

EC Number:

230-991-7

EC Name:

Butyl glycollate

Cas Number:

7397-62-8

Molecular formula:

C6H12O3

IUPAC Name:

butyl glycolate

Constituent 2

Reference substance name:

Polysolvan O

IUPAC Name:

Polysolvan O

Constituent 3

Reference substance name:

Glycolic acid-n-butyl ester

IUPAC Name:

Glycolic acid-n-butyl ester

Details on test material:

- Name of test material (as cited in study report): Polysolvan O (butyl glycollate)
- Physical state: liquid
- Analytical purity: 96%
- Impurities (identity and concentrations): chloro acetic acid n-butyl ester (% not stated), butoxy acetic acid n-butylester
- Purity test date: 04.01.1988
- Lot/batch No.: batch from 29.12.1987
- Storage condition of test material: in the dark at 22°C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AK, Kastengrund, Germany
- Age at study initiation: about 3 – 5 months
- Weight at study initiation: 2.1 – 2.9 kg
- Housing: single in cages
- Diet (e.g. ad libitum): standard chow (Altromin 2123 Haltungsdiaet Kaninchen, Altromin GmbH, Lage/Lippe, Germany) ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12 Hrs light/12 hrs dark

IN-LIFE DATES: From: 1988-Jan-19 to 1988-Jan 26

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): neat

VEHICLE
- none

Duration of treatment / exposure:

4 h

Observation period:

30 - 60 minutes, 24, 48 and 72 hours, day 7

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 × 2.5 cm
- Type of wrap if used: gauze patches were secured with adhesive tape and loosely fixed, semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water at the end of the 4 h exposure period
- Time after start of exposure: 4 h

SCORING SYSTEM: according to the OECD 404 procedure (method of Draize)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 30 - 60 min

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0.66

Max. score:

2

Reversibility:

fully reversible

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 30 - 60 min

Score:

0

Max. score:

0

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

0

Results 9

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible

Results 10

Irritation parameter:

edema score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

0

Irritant / corrosive response data:

Overall irritation score (24, 48 and 72 h):
Erythema: 0.2 (all animals)
Edema: 0.1 (all animals)

Any other information on results incl. tables

Individual results:

Time after patch removal	30 – 60 min			24 h			48 h			72 h			7 d
Animal No.	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
Erythema	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0
Edema	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Polysolvan O (butyl glycollate, 96%) was examined for its skin irritating potential in a valid study conducted according to OECD test guideline No. 404 and under GLP conditions. The test substance was not irritating to the rabbit’s skin.

Executive summary:

In a primary dermal irritation study, 3 young adult white rabbits were dermally exposed to 0.5 mL of unchanged Polysolvan O (butyl glycollate, 96 %) for 4 hours under semi-occlusive condition. The animals were observed for up to 7 days.  Irritation was scored according to the method of Draize (cf. OECD TG 404).

Erythema and edema were not seen at the 30 - 60 min, 24 and 48 h readings. At 72 h only 1/3 rabbits revealed a transient erythema and edema (grade 2 and 1, respectively), which disappeared until day 7. Thus, Polysolvan O (butyl glycollate, 96 %) was not a dermal irritant.

CONCLUSION

Polysolvan O (butyl glycollate, 96 %) was examined for its skin irritating potential in a valid study conducted according to OECD test guideline No. 404 and under GLP conditions. The test substance was not irritating to the rabbit’s skin.