Registration Dossier

Administrative data

Description of key information

Skin irritation

In a dermal irritation study conducted according to OECD 404 guideline in compliance with GLP, one healthy adult rabbit of the Whiter Russian strain was exposed to 0.5 ml of DIHP, diisopropylbenze hydroperoxide at 55% in diisopropylbenzene, at one skin site on the back (Murmann, 1989). Test site was covered with a dressing held in place for 4 hours, 1 hour and 3 minutes. The skin reactions were assessed at 1, 24, 48, 72 hours and 6 days after dressing removal. Application of DIHP resulted in erythema and oedema after 1h and 4h application time. This could be observed after 1h observation period at a sore of 4/4 for both erythema and oedema and could still be observed at this same score after 6 days of observation. Additionally, necrosis could be observed over the 6 days too. After an exposure time of 3 min, no necrosis was observed.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: small white russian Chbb-SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Karl Thomae GmbH, Biberach
- Age at study initiation: no data
- Weight at study initiation: 2.4 kg
- Housing: alone in stainless steel cage
- Diet (e.g. ad libitum): "K4 Alleindiät für Kaninchen" ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 60%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14/04/1989 To: 18/04/1989
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm3
Duration of treatment / exposure:
4h, 1h and 3min
Observation period:
1 , 24, 48 and 72 hours and 6 days after removal of the dressing
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: no data
- Type of wrap if used: elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): softly with warm water
- Time after start of exposure: 3 min, 1 hour, and 4hours

SCORING SYSTEM: according to OECD guideline 404
Irritation parameter:
erythema score
Remarks:
4-h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4-h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Right after the patch removing following the 4 h exposure, signs of necrose could be observed, parchementy-like effect at 24h and 48h, and dark-brown scrab after 72h and 6d.
After a period of 1Hr, necrosis also occurred but not after an exposure time of 3 Min
Other effects:
no other effects were observed.

no additionnal data

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Under the conditions of the test, the test substance would be classified as corrosive category 1B according to the criteria of the CLP Regulation (1272/2008).
Executive summary:

In a dermal irritation study conducted according to OECD 404 guideline in compliance with GLP, one healthy adult rabbit of the Whiter Russian strain was exposed to 0.5 ml of DIHP, diisopropylbenze hydroperoxide at 55% in diisopropylbenzene, at one skin site on the back. Test site was covered with a dressing held in place for 4 hours, 1 hour and 3 minutes. The skin reactions were assessed at 1, 24, 48, 72 hours and 6 days after dressing removal.

Application of DIHP resulted in erythema and oedema after 1h and 4h application time. This could be observed after 1h observation period at a sore of 4/4 for both erythema and oedema and could still be observed at this same score after 6 days observation. Additionnally, necrosis could be observed over the 6 days too. After an exposure time of 3 min, no necrosis was observed.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Diisopropylbenzene hydroperoxide in diisopropylbenzene (Purity: 55.9 %) is classified Corrosive category 1B and Eye irritant category 1. H314 is required.