Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Open application, 72 h observation is missing
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, UK
- Weight at study initiation: 2.5-3.0 kg
- Housing:In satinised aluminium steel cages (605 mm width x 490 mm depth x 455 mm height) with one animal per cage
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 50-60

Test system

Type of coverage:
open
Preparation of test site:
shaved
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): 100%


Duration of treatment / exposure:
3 minutes
Observation period:
Immediately after washing and 2, 24, 48 and 96 h after treatment
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Whole flank

REMOVAL OF TEST SUBSTANCE
- Washing (if done): By gentle swabbing with cotton wool soaked in lukewarm water
- Time after start of exposure: 3min

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average 24 and 48h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 96h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average 24 and 48h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 96h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average 24 and 48h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 96h
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: average 24 and 48h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 96h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: average 24 and 48h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 96h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: average 24 and 48h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 96h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average 24 and 48h
Score:
3.5
Max. score:
4
Reversibility:
fully reversible within: 96h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average 24 and 48h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 96h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average 24 and 48h
Score:
3.5
Max. score:
4
Reversibility:
fully reversible within: 96h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: average 24 and 48h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 96h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: average 24 and 48h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 96h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: average 24 and 48h
Score:
3.5
Max. score:
4
Reversibility:
fully reversible within: 96h
Irritant / corrosive response data:
All animals showed signs of necrosis nintety-six hours after application; these included, typically, thickening of the skin at the application site, eschar formation and blanching and one animal had darkened skin at the appliction site (see table 2).

Any other information on results incl. tables

Table 1: Corrosive reactions

Number of animals with corrosion/all tested animals after

3min

24h

48h

0/6

0/6

1/6

Table 2: Skin corrosion parameters

 

Thickened skin after

Blanched skin after

Hardened skin after

Darkened skin after

Animal number

24h

48h

96h

24h

48h

96h

24h

48h

96h

24h

48h

96h

1

-

-

+

-

-

-

-

-

-

-

-

-

2

-

-

+

-

-

-

-

-

-

-

-

-

3

-

+

+

-

-

-

-

+

+

-

+

+

4

-

+

+

-

-

-

-

-

-

-

-

-

5

-

+

+

-

-

+

-

-

-

-

-

-

6

-

+

+

-

-

-

-

-

-

-

-

-

 

Cracked skin after

Wrinkled skin after

Eschar formation after

Animal number

24h

48h

96h

24h

48h

96h

24h

48h

96h

1

-

-

-

-

-

-

-

-

-

2

-

-

-

-

-

-

-

-

-

3

-

-

-

-

-

-

-

+

+

4

-

-

-

-

-

-

-

-

-

5

-

-

-

-

+

-

-

-

-

6

-

-

-

-

-

-

-

-

-

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Undiluted Synprolam 35x2 when administered to rabbit skin for 3 min is corrosive to one out of 6 animals after 48h observation time and 6 out of 6 animals after 96 h observation time and therefore is classified:
CLP: Category 1B, H314 (causes severe skin burns)