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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:
Aug 2002 to Feb 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- exposure time 24 hrs instead of 4 hrs, few details in test description and reporting
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptanoic anhydride
EC Number:
210-940-5
EC Name:
Heptanoic anhydride
Cas Number:
626-27-7
Molecular formula:
C14H26O3
IUPAC Name:
heptanoic anhydride
Constituent 2
Reference substance name:
Heptanoic acid anhydride
IUPAC Name:
Heptanoic acid anhydride

Test animals

Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH, Schönwalde, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 276-313 g (males), 188-193 g (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23°C
- Humidity (%): 54-62 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated skin served as control
Amount / concentration applied:
0.64-0.67 mL / male animal or 0.40 -0.42 mL / female animal (= 2000 mg/kg bw)
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3 males and 3 females
Details on study design:
Skin areas were assessed 1, 24, 48 and 72 hours after the end of administration. Evaluation of skin reactions(reddening, scab formation and swelling of the skin) was done according to the system recommended in Directive 67/548/EEC.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.95
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight to slight skin reddening was noted in all animals treated with 2000 mg/kg bw. In addition, desquamation was observed in all female animals and in two male animals. The local intolerance reactions observed in rats were reversible within 11 days after administration. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0 for swelling and 0.95 for reddening and scab formation (see table 1).

Any other information on results incl. tables

Table 1: Mean values of findings relevant for classification.

Test compound ZK 56406 (2000 gm/kg)

Animal number and sex

Location (finding)

Time-point after end of exposure

10M

11M

12M

4F

5F

6F

Reddening and scab formation

1 hour*

0

0

2

2

2

2

24/25 hours

1

0

1

2

2

2

48 hours

1

0

1

2

1

1

72 hours

0

0

1

1

1

0

Individual mean values:

0.67

0

1.0

1.67

1.33

1.0

Mean value of all animals:

0.95

 

Swellings

1 hour*

0

0

0

0

0

0

24/48 hours

0

0

0

0

0

0

48 hours

0

0

0

0

0

0

72 hours

0

0

0

0

0

0

Individual mean values:

0

0

0

0

0

0

Mean values of all animals:

0

M = male

F = female

*         = not included in calculations of mean values

Applicant's summary and conclusion

Interpretation of results:
other: slight local intolerance reactions noted up to day 8.
Executive summary:

A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg (0.64-0.67 mL / male or 0.40 -0.42 mL / female) led to slight local intolerance reactions up to day 8 after administration. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0 for swelling and 0.95 for reddening and scab formation.

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