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Diss Factsheets

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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-GLP study following a method equivalent to a recognised OECD guideline. Deviations to recognised guideline are noted. Applicant evaluated and/or recalculated the individual and mean scoring, where necessary.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Occlusive dressing smaller exposure area (2.5cm2), longer exposure period (24h) shorter observation period (48h)
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.41
Version / remarks:
To identify dermal irritation potential as defined in 16 CFR 1500.3(c)(3)(4)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reaction products of ((5E)-5-ethylidenebicyclo[2.2.1]hept-2-ene and (5Z)-5-ethylidenebicyclo[2.2.1]hept-2-ene) and 2-methyl-1,3-butadiene, epoxidized
EC Number:
942-422-6
Molecular formula:
Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
IUPAC Name:
Reaction products of ((5E)-5-ethylidenebicyclo[2.2.1]hept-2-ene and (5Z)-5-ethylidenebicyclo[2.2.1]hept-2-ene) and 2-methyl-1,3-butadiene, epoxidized
Test material form:
other: liquid
Details on test material:
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: at least 8 weeks
- Weight at study initiation:
- Housing: housed 2/cage in suspended wire mesh cages (30" x 18" x 18")
- Diet: rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped / abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): neat (liquid)
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
1 males; 5 females (6 in total)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2
- % coverage: Not reported. The fur was clipped from the backs and sides of the animals. The back to the left of the spinal column of all animals was abraded. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding. The back to the right of the spinal column remained intact.
- Type of wrap if used: Occlusive (gauze wrapped with imperivous material)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure: Not applicable.

SCORING SYSTEM: Draize-scoring system. The mean values (6 rabbits) for erythema/eschar and edema formation on intact and abraded skin at 24 and 72 hours (a total of 8 values) are added and divided by 4 to give the Primary lrritation score. By the criteria of this test, Primary lrritant means a substance which is not corrosive, but which results in an empirical score of 5 or more. References: 16 CFR 1500.41 and 16 CFR 1500.3.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
(n=6) rabbits
Time point:
24/48/72 h
Score:
1.17
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(n=6) rabbits
Time point:
24/48/72 h
Score:
0.833
Max. score:
4
Reversibility:
other: Full reversibilty was observed within 72 hours within 3/6 rabbits
Remarks on result:
other: Time points 24 and 72hours are used in intact skin
Remarks:
USA Federal Hazardous Substances Act tests to 16 CFR 1500.3 terminate observations at 72hours.USA Federal Hazardous Substances Act tests to 16 CFR 1500.3 terminate observations at 72hours.
Irritation parameter:
edema score
Basis:
mean
Remarks:
(n=6) rabbits
Time point:
24/48/72 h
Score:
0.34
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Time points 24 and 72hours are used in intact skin
Remarks:
USA Federal Hazardous Substances Act tests to 16 CFR 1500.3 terminate observations at 72hours.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
4
Remarks on result:
probability of mild irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
1
Max. score:
4
Remarks on result:
probability of mild irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
1
Max. score:
4
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Remarks:
intact skin
Irritant / corrosive response data:
Very slight to well defined erythema was noted during the observation period. Scores decreased from 24 to 72 hours.
Very slight to slight edema was noted at 24 hours. All 72 hour edema scores were zero.

Any other information on results incl. tables

Table 1. Skin reactions (using Draize scoring method)

Erythema & Eschar Formation Hours Rabbit number Mean score
1 2 3 4 5 6
Intact skin 24 1 1 1 2 1 1 1.17
72 0 1 0 1 0 1 0.50
Abraded skin 24 1 1 1 2 1 1 1.17
72 0 1 0 0 0 0 0.33
 
Edema                
Intact skin 24 1 0 0 1 1 1 0.67
72 0 0 0 0 0 0 0.00
Abraded skin 24 1 0 0 1 1 2 0.83
72 0 0 0 0 0 0 0.00
                 
Sum of mean scores 4.67
Primary irritation index = sum of mean scores/4 1.17

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
EU criteria not met
Conclusions:
Under the conditions of this study the test substance is not considered to be irritating to the skin of New Zealand white rabbits.
Executive summary:

The pre-GLP study was completed under 16 CFR 1500.41 following a guideline similar to OECD 404, to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The test substance was evaluated in 6 New Zealand white rabbits. A dose of 0.5 ml test substance was applied to intact and abraded clipped dorsal skin site under a occlusive dressing for 24 hours. Skin observations were made 24 and 72 hours after patch removal. Very slight to well defined erythema was noted during the observation period. Scores decreased from 24 to 72 hours. Very slight to slight edema was noted at 24 hours. All 72 hour edema scores were zero. The test material produced a mean primary irritation index (PII) of 1.17 and is considered to be non-irritating to skin.