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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21-12-1976 - 24-01-1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Results are from an in vivo test conducted before the Reach regulation came into force requesting in vitro information.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Observations up to 72 hr, scoring system was not according to OECD-method
GLP compliance:
no
Remarks:
Pre-GLP

Test material

1
Chemical structure
Reference substance name:
Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
EC Number:
916-331-7
Molecular formula:
C14H20O2
IUPAC Name:
Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 - 12 weeks

ENVIRONMENTAL CONDITIONS
No information available

IN-LIFE DATES: No information available

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100%

VEHICLE
Not applicable
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
10
Details on study design:
TEST SITE
- Area of exposure: Whole dorsal surface
- % coverage: no information available
- Type of wrap if used: Occlusive patches were prepared by heat-sealing 1"x1" 24 ply gauze pads on to 1.25"x1.25" squares of polythene sheeting which is then attached to 3.5"x1" strips of adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after patch removal, treatment sites were wiped clean of excess material
- Time after start of exposure: 4 hours

SCORING SYSTEM: An 8-point anchored ordinate scale ranging from 'a' (very slight) to 'h' (severe) was used to score the treatment sites for erythema, oedema, cracking and scaling and any other feature:

Reaction grades and scores:
A: Marginal / very slight = 1
B: Slight = 2
C: Fairly distinct = 3
D: Quite distinct = 4
E: Becoming well developed = 6
F: Well developed = 8
G: Becoming severe = 10
H: Severe = 12

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal: #8
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal: #8
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritant / corrosive response data:
Gardocyclene, as supplied, caused very slight to slight skin irritation in New Zealand White rabbits after 4 hours of semi-occlusive exposure.

Any other information on results incl. tables

Rabbit

Total scores (4, 24, 48, 72 hours)

Total score

Erythema

Oedema

Cracking

Scaling

2429

10

10

6

4

30

2431

9

7

11

10

37

2510

4

3

6

3

16

2513

7

3

4

2

16

2516

10

6

10

9

35

2469

8

3

4

3

18

2504

5

4

7

6

24

2499

11

5

8

6

30

Overall Irritation Score

206.00

Mean score per site

25.75

Mean score per site per day

6.44

Applicant's summary and conclusion

Interpretation of results:
other: Not a skin irritant
Remarks:
according to EU CLP (1272/2008/EC and its updates.
Conclusions:
In a skin irritation study in rabbits which was performed according to a method which is equivalent to OECD 404, Cyclabute is not a skin irritant.
Executive summary:

The ability of Cyclabute to induce skin irritation in rabbits was investigated in a skin irritation study which was performed according to a method which is equivalent to OECD404 (pre-GLP). The test material was applied to the clipped dorsum skin for 4 hours under a semi-occlusive dressing. After removal of the patches, the treatment sites were wiped clean of excess material and examined for evidence of irritation. Further assessemnts were made at 24, 48 and 72 hours after treatment. Cyclabute caused very slight to slight skin irrtiation. The scores indicate absence of irritation.