Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1994-12-06 to 1994-12-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from a guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino, Chbb: NZW (SPF)
Details on test animals and environmental conditions:
TEST ANIMALS
- Sex: male/female
- Age at study initiation: 3-5 month
- Weight at study initiation: 2.1 - 2.4 kg
- Housing: single housing
- Diet: ad libitum, laboratory rabbit diet Altromin 2123 and in addition hay (15 g daily)
- Water: ad libitum, tap water
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/patch, prepared to paste with 0.45 ml 0.9 % NaCl
Duration of treatment / exposure:
4 h
Observation period:
72 h
scorings 30-60 min, 24, 48 and 72 hours after test substance removal
Number of animals:
3
Details on study design:
PREPARATION OF ANIMALS
- An dorasal area of ca. 25 cm² was clipped 24 h before treatment.

TEST SITE
- Area of exposure: patches of 2.5 x 2.5 cm, loaded with 500 mg test substance prepared to paste with 0.45 ml 0.9 % NaCl/patch
- Type of wrap if used: cellulose patch (custom product from Beiersdorf AG, Hamburg, Germany), was held in place with a semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, washing with lukewarm tap water
- Time after start of exposure: 4 h

OBSERVATION
- Signs for erythema and edema were recorded 30-60 min, 24, 48, 72 h after removing of patches

SCORING SYSTEM:
- as stipulated by OECD 404 (Draize scheme)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #3
Time point:
other: mean 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal: #2
Time point:
other: mean 24, 48, 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal: #1, #2
Time point:
other: mean 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal: #3
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
30 to 60 minutes after patch removal, 3/3 animals showed well defined erythema (score 2) and 1/3 animals each very slight oedema (score 1) or slight edema (score 2), 1/3 animals was free of edema at this observation. At the 24 hours scoring, erythema had lessened in 2/3 animals to score 1 and worsened in 1/3 animal to score 3. At the 24 hours scoring 2/3 animals showed an edema score 1. The only skin reaction still present at the 48 hours scoring, was a erythema score 2 in 1/3 animals. Fully reversibility in all animals was reached for erythema at the 72 hours scoring and for edema at the 48 hours scoring.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 2

30-60 min

2/2/2

1/2/0

24 h

1/3/1

1/1/0

48 h

0/2/0

0/0/0

72 h

0/0/0

0/0/0

Average 24h, 48h, 72h

0.33/1.67/0.33

0.33/0.33/0

Reversibility*)

c

c

Time for reversion (h)

48/72/48

48

*) Reversibility: c. = completely reversible; n.c.= not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information spray dried, 99.4% a.i. Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Classification is based on erythema/eschar and oedema calculated as mean scores following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.
No classification for skin irritation is justified for the "Coco AAPB (99.4 % dry solids)" according to CLP, EU GHS (Regulation (EC) No 1272/2008).
Executive summary:

In a primary dermal irritation study according to EU Method B.4 (1992) and OECD Guideline 404 (1992), 3 New Zealand White rabbits were dermally patch (2.5 x 2.5 cm²) exposed for 4 hours to 0.5 g of Coco AAPB (99.4 % dry solids) moistened with physiological saline. Test sites were covered with semi-occlusive dressing. Animals were then observed for 72 hours. Irritation was scored according to Draize as stipulated in the OECD guideline.

30 to 60 minutes after patch removal, 3/3 animals showed well defined erythema (score 2) and 1/3 animals each very slight edema (score 1) or slight edema (score 2), 1/3 animals was free of edema at this observation. At the 24 hours scoring, erythema had lessened in 2/3 animals to score 1 and worsened in 1/3 animal to score 3. At the 24 hours scoring 2/3 animals showed an edema score 1. The only skin reaction still present at the 48 hours scoring, was a erythema score 2 in 1/3 animals. Fully reversibility in all animals was reached for erythema at the 72 hours scoring and for edema at the 48 hours scoring.

In this study, Coco AAPB (99.4 % dry solids) is not a dermal irritant.