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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparing to guidelines/standards, basic data is given.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: no data (see comments)
Principles of method if other than guideline:
comments: In this skin irritation study, no details test guideline was presented. However, it is indicated that 10 animals (unspecified sex) per dose and only one dose levels: 5000 mg/kg. The results included redness and edema effects and necropsy observations.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Aldehyde AA (Triplal)

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
Number of animals:
10 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: redness
Basis:
animal: 1/8
Remarks on result:
other: Moderate redness
Irritation parameter:
other: redness
Basis:
animal: 7/8
Remarks on result:
other: Servere redness
Irritation parameter:
edema score
Basis:
animal: 4/8
Remarks on result:
other: Moderate edema
Irritation parameter:
edema score
Basis:
animal: 4/8
Remarks on result:
other: Severe edema

Any other information on results incl. tables

Table 1. Necropsy observation

Doses (mg/kg) 5000
Skin, sloughing of exposure area 1
Skin edema 8
Skin redness  
Skin, hard/thick  

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance Ligustral/Cyclal C/Trigustral was irritating to the skin of rabbits.
Executive summary:

In a dermal toxicity study (1699 02/03), a 5000 mg/kg bw dose of Ligustral/Cyclal C/Trigustral was applied to the skin of 10 rabbits. Irritation was assessed according to the following irritation parameters: skin redness, skin oedema, skin sloughing of exposure area and skin (hard/thickness).

On Day 1, two animals died. The number of rabbits showing skin irritation was: 1/8 moderate redness, 7/8 severe redness; 4/8 moderate oedema, 4/8 severe oedema. The following observations were noted during necropsy of all animals: skin sloughing of exposure area, 1/10; skin oedema, 7/8, skin redness, 9/10, and skin hard/thicknes, 6/10.

In this study, Ligustral/Cyclal C/Trigustral is a skin irritant.