Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09.08.05 to 12.10.05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP, using a closely-related test substance.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
09.08.05 to 12.10.05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP, using a closely-related test substance.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No deaths occurred
Mortality:
All animals survived until scheduled termination of the study.
Clinical signs:
There were no clinical signs of toxicity.
Body weight:
Body weight loss was noted in 1/5 females in the first week. The authors concluded that this might have been caused by the discomfort of the dressing and was not considered to be toxicologically significant. Body weights and body weight gains were normal in the second week. There were no effects on male body weights.
Gross pathology:
There were no abnormal findings during the gross pathological examination.
Other findings:
No other findings.
Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In a good quality acute dermal toxicity study (reliability score 1) conducted to OECD test guideline 402, and GLP, the LD50 for Crude Tall Oil , which has a chemical composition similar to that of Distilled Tall Oil, was greater than 2000 mg/kg bw in Crl:CD(SD)IGS BR rats. It can therefore be concluded that the acute dermal LD50 of Distilled Tall Oil is also >2000 mg/kg.
Executive summary:

This data is being read across from the source study that tested Crude Tall Oil based on analogue read across.

 

Read-across from CTO to DTO is justified on the grounds that all the chemical constituents that are present in DTO are present in CTO i.e. fatty acids, resin acids, polymers and neutral compounds containing alcohols, hydrocarbons etc. The chemical constituent blocks of which they are comprised are compositionally very similar and are made up of constituents with common functional groups and properties. As a result the substances share very similar physicochemical properties both in terms of their bulk properties and the properties of the constituent blocks. CTO does contain some constituents that are not present in DTO and for this reason read-across from DTO to CTO is not considered appropriate. However for the purposes of read-across from CTO to DTO this is only likely to make the outcome conservative i.e. if anything the hazard of DTO is likely to be overestimated. A more detailed description of the technical justification for read-across is given in Section 1.4 of the CSR.

A single dermal administration of Crude Tall Oil was performed, by spreading the test substance on an area of skin that was at least 10% of the estimated body surface of male and female CRL: CD(SD)BR SPF rats. 2000 mg/kg bw of the test substance was held in place with a semi-occlusive dressing for 24 hours. At the end of the exposure period the residual test substance was wiped off with a wet cellulose tissue, when necessary. The animals were then observed for 14 days. Clinical observations were noted at least once per day, body weights were recorded before administration, and on days 7 and 14. At the end of the observation period all animals were sacrificed and necropsied. There were no clinical signs of toxicity, no deaths and there were no treatment-related effects on body weight. The dermal LD50 was therefore greater than 2000 mg/kg bw.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Crude Tall Oil
- Substance type: Complex mixture
- Physical state: Brown liquid
- Analytical purity: No data
- Composition of test material, percentage of components: Complex mixture
- Purity test date: No data
- Lot/batch No.: 2005-06-09, sample 4.
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Room temperature, in the dark.

Test animals

Species:
rat
Strain:
other: CRL: CD(SD)BR SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: Males: 8 weeks. Females: 12 weeks.
- Weight at study initiation: Males: 270 - 284 g. Females: 245 - 252g.
- Fasting period before study: No
- Housing: Individually in Makrolon cages Type III
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (average)
- Humidity (%): 67 (average)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 09.08.05 To: 25.08.05

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 52 cm2
- % coverage: 10% of estimated body surface.
- Type of wrap if used: Cellulose patch was held in place by a non-irritating tape. The patch and tape were covered semi-occlusively by a dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with wet cellulose tissue.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed 0-0.5, 0.5-1, 1-2, 2-4 and 4-6 hours after administration of the test substance and then at least once per day for two weeks. Body weights were recorded before administration and on Days 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No deaths occurred
Mortality:
All animals survived until scheduled termination of the study.
Clinical signs:
There were no clinical signs of toxicity.
Body weight:
Body weight loss was noted in 1/5 females in the first week. The authors concluded that this might have been caused by the discomfort of the dressing and was not considered to be toxicologically significant. Body weights and body weight gains were normal in the second week. There were no effects on male body weights.
Gross pathology:
There were no abnormal findings during the gross pathological examination.
Other findings:
No other findings.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In a good quality acute dermal toxicity study (reliability score 1) conducted to OECD test guideline 402, and GLP, the LD50 for Crude Tall Oil , which has a chemical composition similar to that of Distilled Tall Oil, was greater than 2000 mg/kg bw in Crl:CD(SD)IGS BR rats. It can therefore be concluded that the acute dermal LD50 of Distilled Tall Oil is also >2000 mg/kg.
Executive summary:

A single dermal administration of Crude Tall Oil was performed, by spreading the test substance on an area of skin that was at least 10% of the estimated body surface of male and female CRL: CD(SD)BR SPF rats. 2000 mg/kg bw of the test substance was held in place with a semi-occlusive dressing for 24 hours. At the end of the exposure period the residual test substance was wiped off with a wet cellulose tissue, when necessary. The animals were then observed for 14 days. Clinical observations were noted at least once per day, body weights were recorded before administration, and on days 7 and 14. At the end of the observation period all animals were sacrificed and necropsied. There were no clinical signs of toxicity, no deaths and there were no treatment-related effects on body weight. The dermal LD50 was therefore greater than 2000 mg/kg bw.