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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:
1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
- The test performance was similar to OECD guideline, however with few deviations (occlusive test conditions, 1ml test substance applied, exposure periods of 1, 5, 15 minutes and 20 hours, additionally testing of the ear) that did not affect the validity of the results for assessment. - The study is scientifically acceptable.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968
Reference Type:
other: Translation of original German report dated 1968-10-21
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 2002)
Deviations:
yes
Remarks:
, occlusive test conditions, 1ml test substance applied, exposure periods of 1, 5,15 minutes and 20 hours, additionally testing of the ear.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Butandiolformal (1,3-Dioxacycloheptane)
Purity 99.99%
Physical state: liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
- Designation: no data
- Source: no data
- Age at study initiation: no data
- Weight at study initiation:
Animal 1: 2.55 kg
Animal 2: 3.08 kg
Animal 3: 2.90 kg
Animal 4: 2.90 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
ca. 1 ml
Duration of treatment / exposure:
1, 5 and 15 min, 20h
Observation period:
8 days
Number of animals:
One animal (animal 1) received dorsal applications of test substance for 1, 5, 15 minutes and for 20 hours, and a 20 hour application on the ear;
One animal (animal 2) received dorsal applications of test substance for 1, 5, 15 minutes and for 20 hours, and a 20 hour application on the ear;
One animal (animal 3) received dorsal application of test substance for 20 hours, and a 20 hour application on the ear;
One animal (animal 4) received dorsal application of test substance for 20 hours, and a 20 hour application on the ear;
Details on study design:
Skin irritation was tested using an internal method (BASF test). The test substance was applied unchanged on the backs of 2 animals for 1, 5 and 15 minutes. The application sites were rinsed with Lutrol and Lutrol in water 1:1. The test substance was also applied for 20 hours on the back of two other animals, without rinsing. Each animals further received a 20 hour application on the ear, without rinsing.
The animals were observed for 8 days and skin changes were recorded. Scoring was perfomed at following time points: 24h, 48h, 72h, day 6, and day 8

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: (20 hour dorsal application)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1.66
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: (20 hour dorsal application)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: (20 hour dorsal application)
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: (20 hour dorsal application)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: (20 hour dorsal application)
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: (20 hour dorsal application)
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: (20 hour dorsal application)
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: (20 hour dorsal application)
Irritant / corrosive response data:
ANIMAL 1:
Dorsal application for 1, 5, 15 minutes: no effects were seen
Dorsal application for 20 hours: questionable redness seen after 24 and 48 hours; replaced by fine scaling after 72 hours, no more effects at day 6, no edema.
ANIMAL 2:
Dorsal application for 1, 5, 15 minutes: on all 3 application sites, questionable erythema was seen after 24 hours, but no edema. On the 1 min. application site, no more effects were seen after 48 hours. On the 5 min. application site, questionable erythema lasted for 72 hours and was no more seen thereafter; no edema. On the 15 min. application site, questionable erythema lasted for 72 hours; at time point 72 hours, fine scaling was seen, that lasted until day 6; no edema.
Dorsal application for 20 hours: questionable redness was seen after 24 hours, which turned to well-defined after 48 hours and lasted until 72 hours. Redness was accompanied by slight edema (24 to 72 hours). The findings were no more evident from day 6.
ANIMAL 3:
Dorsal application for 20 hours: questionable erythema lasting for 72 hours was reported, but no edema.
ANIMAL 4:
Dorsal application for 20 hours: questionable erythema lasting for 72 hours was reported, but no edema.
Other effects:
ANIMAL 1:
Ear application for 20 hours: moderate to severe redness, necrosis, open, bloody blebs seen after 24 hours, until day 8.
ANIMAL 2:
Ear application for 20 hours: open, bloody blebs seen after 24 hours, until day 8.
ANIMAL 3:
Ear application for 20 hours: questionable redness, necrosis and partly open blebs seen after 24 hours, until day 6.
ANIMAL 4:
Ear application for 20 hours: questionable redness, necrosis and partly open blebs seen after 24 hours, until day 6.

Applicant's summary and conclusion