Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
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:
In this acute dermal toxicity study, no details test guideline was presented. However, it is indicated that 10 animals (unspecified sex) were dosed in a limit test (5000 mg/kg). The results provided were: mortality, time of death of individual animals, signs of toxicity, necropsy findings.
GLP compliance:
not specified
Test type:
other: no data
Limit test:
yes

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
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 animals per dose and unspecific sex
Control animals:
no
Details on study design:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
At 5000 mg/kg dose: 2/10 deaths (by day 2)
Clinical signs:
At 5000 mg/kg dose: anorexia, lessened mobility due to severe edema & eschar of exposure site, ptosis - Animal 1 - days 6 through day 14. Emaciated - Animal - day 14.

Any other information on results incl. tables

Table 1: Necropsy observations

Doses (mg/kg) 5000
Normal
Cannibalized
Exudate, nose/mouth, red
Exudate, nose/mouth, yellow 2
Exudate, nose/mouth, clear
Exudate, nose/mouth, brown
Intestines, areas red
Intestines, areas yellow 1
Intestines, bloated 1
Intestines, contained dark green substance 1
Stomach bloated
Liver dark 5
Liver mottled 1
Lungs, white nodules
Lungs, areas dark 2
Lungs, dark
Lungs, flourescent red
Kidney dark
Kidney mottled 2
Kidney pale 1
spleen dark
spleen large
spleen mottled
Skin, sloughing of exposure area 1
Skin edema 8
Skin redness
Skin, hard/thick
Bladder, blood contained

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of Ligustral/Cyclal C/Trigustral in rabbits was found to be greater than 5000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study (1699 02/03), 10 rabbits were given single dermal dose of Ligustral/Cyclal C/Trigustral at 5000 mg/kg bw and observed up to 14 days after dosing.

Dermal LD 50: >5000 mg/kg bw

There were 2/10 deaths on day 1. Signs of toxicity noted in animal 1 from day 6 through day 14 were anorexia, lessened mobility due to severe edema & eschar of exposure site and ptosis; animal 1 was emaciated by day 14. The following observations were noted during necropsy of all animals: intestines, liver, lungs, kidney and spleen showed abnormalities that appeared dose related. The stomach and bladder showed sporadic abnormalities. Skin sloughing of the exposure area (1/10); skin oedema (7/8), skin redness (9/10) and skin hard/thickness (6/10) were also noted.