Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
February 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This is a GLP guideline study and is used in read-across from Alchisor CAL 123 (see 'Read Across Justification Document'). The study merits a Klimisch 1 rating; Klimisch 2 when used for read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
Temperature and humidity were outside protocol range but did not affect study outcome.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Alkenes, C11-12, hydroformylation products, distn. residues; Alchisor CAL (Commercial Name)
- Substance type: pure active substance
- Physical state: colourless liquid
- Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Nichols Rabbitry Inc., Lumberton, TX, USA
- Age at study initiation: approx. 3 month
- Weight at study initiation: 2.15 - 2.55 kg
- Housing: in suspended, wire-bottomed, stainless steel cages, 1 animal per cage
- Diet (e.g. ad libitum): Lab Rabbit Diet #5321 (PMI Feeds Inc.), approx. 8 oz. per day
- Water (e.g. ad libitum): Municipal water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 (outside protocol range)
- Humidity (%): 22 - 68 (outside protocol range)
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2010-02-16 To: 2010-02-26

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the contralateral intact side of the trunk served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal
Number of animals:
3 (2 male, 1 female)
Details on study design:
TEST SITE
- Area of exposure: 8 x 8 cm hair-free clipped area on the dorsal trunk
- % coverage: not mentioned
- Type of wrap if used: The test site was covered with a 4 ply, 2.5 x 2.5 cm surgical gauze patch, secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (othopedic stockinette) wich was secured on both edges with strips of tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with room temperature tap water and a clean cloth to remove as much residual test substance as possible
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to Draize, John H., Woodward, Geoffrey, and Calvery, H.O., Methods for the Study of Irriation and Toxicity of Substances Applied Topically to the Skin and Mucous Menbranes, J.Pham & Ther. 82, 377 (1944)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
8
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0
- Edema: 0
REVERSIBILITY: not applicable
Other effects:
No other signs of skin irritation were recorded. One animal was found dead on Day 1 of the study; no irritation had been observed at 1 hour after dosing, and the death was not considered related to the administration of the test substance. A replacement animal was dosed following a quarantine period and used for calculations and determinations in the study.

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: 4

60 min

0/0/0

 0/0/0

24 h

 0/0/0

 0/0/0

48 h

 0/0/0

 0/0/0

72 h

 0/0/0

 0/0/0

Average 24h, 48h, 72h

 0

 0

Reversibility*)

 -

 -

Average time (unit) for reversion

 -

 -

 

*) 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 Criteria used for interpretation of results: EU
Conclusions:
Erythema and edema were not observed at any time throughout the study. No other signs of irritation were observed during the study. The primary irritation index of 0.0 of a possible 8.0 was obtained from the observations at 24, 48 and 72 hours, and was used to give the test substance Alkenes, C11-12, hydroformylation products, distn. residues (CAS No.: 90622-27-8) a descriptive rating of non-irritant.
Executive summary:

A primary dermal irritation study was conducted in three albino rabbits using test substance Alkenes, C11 -12, hydroformylation products, distn. residues (CAS No: 90622 -27 -8). There was one intact test site per animal. Each test site was treated with 0.5 mL of the undiluted test substance and covered with a semi-permeable dressing. The test substance was maintained in contact with the skin for 4 hours. Observations for dermal irritation and defects were made at 1, 24, 48 and 72 hours after removal of the dressings. Erythema and edema were not observed at any time throughout the study. No other signs of irritation were observed during the study. One animal was found dead on Day 1 of the study; the death was not considered related to the administration of the test substance. A replacement animal was dosed. Based on the Primary Irritation Index (PII) of 0.0, the test substance was rated non-irritating.