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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Study predates GLP but is sufficiently documented, meets generally accepted scientific principles and is acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Ony 4 males tested at each dose; no follow-up assessment in females. Occlusive covering. Limited detail of clinical examinations and pathology.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no details
- Age at study initiation: 3-5 months
- Weight at study initiation: no details
- Fasting period before study: no details
- Housing: no details
- Diet (e.g. ad libitum): no details
- Water (e.g. ad libitum): no details
- Acclimation period: no details

ENVIRONMENTAL CONDITIONS
no details

IN-LIFE DATES: no details

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: no details
- % coverage: no details
- Type of wrap if used: polyethylene

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance 'removed' after exposure
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4, 8 and 16 ml/kg bw (no further details).
- Concentration (if solution): neat
Duration of exposure:
24 h
Doses:
4, 8 and 16 ml/kg bw
No. of animals per sex per dose:
4 males/dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no details
- Necropsy of survivors performed: apparently yes - very limited details given
- Other examinations performed: body weight - very limited details given

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
11.3 mL/kg bw
95% CL:
5.19 - 24.7
Mortality:
See table 1.
Clinical signs:
None reported.
Body weight:
See table 1; no further details given.
Gross pathology:
See table 1; no further details given.
Other findings:
- Organ weights: not measured
- Histopathology: see table 1
- Potential target organs: insufficient detail available

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity, and time range within which mortality occurred

Dose
(ml/kg bw)

Mortality (# dead/total)

Time range of deaths (days)

Local skin effects

Pathology

Body weight change (g)

[as reported – initial body weight not given]

4

0/2

-

Scabbing in1 of 2 on day 14

In fatalities: discoloured liver  (mottled red and tan, white spots) and kidneys (tan).

In survivors: discoloured livers (dark red) and kidneys (mottled tan and red).

4; 61

8

1/4

9

Erythema, oedema, desquamation and necrosis; full details not presented.

-784 to 239 (mean 239)

16*

3/4

1, 2, 4

Erythema, oedema, desquamation, necrosis and fissuring in the survivor; full details not presented.

59

* two different samples of test substance used for 2 rabbits in each case

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A brief summary of a limited study, for which neither guideline nor GLP status were reported, recorded an LD50 in the rabbit of 11.3 ml/kg bw.