Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Test was conducted according to methods similar to OECD 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Lime Oil
IUPAC Name:
Lime Oil
Details on test material:
- Name of test material (as cited in study report): Lime oil
- Physical state: liquid
- Lot/batch No.: confidential information

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 to 3.0 kg.
- Housing: individually
- Diet: commercial diet ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 240 cm2
- % coverage: about 10% of body surface
- Type of wrap if used: the test material was delivered under a rubber sleeve by using a hypodermic syringe; then the sleeve was covered with Webril padding. The rabbit was fitted with a collar to prevent the removal of the wrappings.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: after 24 hours later the binders were removed

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg = 4.367 g/kg bw
Duration of exposure:
24 hours
Doses:
5 ml/kg = 4.367 g/kg bw
No. of animals per sex per dose:
6 animals/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, dermal reactions
Statistics:
Not relevant

Results and discussion

Preliminary study:
Not relevant
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 367 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 5.0 ml/kg
Mortality:
1 out of 6 rabbits died on day 3
Clinical signs:
No toxic signs observed
Body weight:
No data available
Gross pathology:
The one rabbit that died showed hemorrhagic lungs. There was no tissue damage observed in rabbits killed at the termination of the study.
Other findings:
Dermal reactions:
Edema*: 1-4 (3/6)
Erythema*: 1-4 (6/6)
Discoloration: + (4/6)
Scaling: + (5/6)
Necrosis: + (5/6)
Eschar Formation: + (5/6)

* = According to Draize's scoring method
+ = Presence
Numbers in parentheses indicate number of animals that showed reactions

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 value of lime oil in rabbits was established as exceeding 4.367 g/kg body weight (5.0 ml/kg bw), under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
Executive summary:

A single 5 ml/kg bw (= 4.367 g/kg bw) dose of lime oil was administered dermally to 6 male/female New Zealand White rabbits. The test was conducted according to methods similar to OECD 402 (limit test) and was performed pre-GLP. The animals were observed for 14 days. One animal out of 6 died on day 3. No symptoms were noted. Dermal reactions, characterized by erythema and edema of varied degrees, were produced by lime oil. Other dermal reactions such as discoloration, scaling, necrosis, and eschar formation also occurred in most of the animals. The one rabbit that died showed hemorrhagic lungs. There was no tissue damage observed in rabbits killed at the termination of the study. The dermal LD50 value of lime oil in rabbits was established as exceeding 4.367 g/kg bw (5.0 ml/kg bw), under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).