Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2006-01-17 to 2006-01-31
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been based on read across and based on use of OECD guideline and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

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
Reference substance name:
Terpineol multi: 8000-41-7
IUPAC Name:
Terpineol multi: 8000-41-7
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Dertol 90
- Substance type: multi-constituent
- Physical state: liquid
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Janvier, Le Genest St Isle, France
- Age at study initiation: approximately 6 weeks old
- Weight at study initiation: males between 228 g and 272 g, and females between 217g and 222 g
- Acclimatisation period: at least 5 days
- Housing: Five animals of the same sex are kept in each makrolon cage, dimensions 47 cm X 31 cm X 19 cm
- Diet (e.g. ad libitum): rats-mice maintenance pelleted diet (ad libitum)
- Water (e.g. ad libitum): tap water from public distribution system (ad libitum)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19 and 25
- Humidity (%): between 30 and 50
- Air changes (per hr): at least 10 cycles
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2006-01-17 To: 2006-01-31

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: 10% of the total body
- Type of wrap if used: porous gauze dressing and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): test group: 2.13 mL/kg body weight
- Concentration: undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): control group: 2 mL/kg body weight of distilled water
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systemic examinations were carried out to identify behavioral or toxic effects on physiological functions at 1, 3, 5, 24 and 48 h after administration of the product. Animals were weighed on D0 before application of the product, D2, D7, and D14.
- Necropsy of survivors performed: yes, performed on D14 for the macroscopic examination of the following organs: oesopahgus, stomach, duodenum, jejunum, ileum, caecum, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, testicles, ovaries, uterus, adrenals, pancreas and treatment area (skin).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
other: No systemic clinical signs were noted.
Gross pathology:
No significant toxic effects.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tthe LD50 of the test item DERTOL 90 is higher than 2000 mg/kg body weight. Therefore it should not be classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (1272/2008).
Executive summary:

Acute dermal toxicity study of Terpineol multi (a multi-constituent substance with alpha-Terpineol as its main constituent and gamma-Terpineol as the minor constituent) as a limit test was conducted according to OECD guideline 402 and in compliance with GLP. To groups of 5 Sprague-Dawley rats/sex were used: one control group exposed to distilled water and one test group. The test substance was applied to the skin by topical application for 24 h, under semi-occlusive conditions, at 2000 mg/kg bw, with a volume of 2.13 mL/kg bw. After exposure, exposure area was washed with distilled water.

Animals were observed every day for systemic clinical signs and mortalities for 14 days. The animals were weighed on D0, D2, D7 and D14. Necropsies were done on D14 for macroscopic observations. No toxic effects were observed.

Based upon these experimental conditions, the LD50 of the Dertol 90 is higher than 2000 mg/kg bw by dermal route in the rat,

and Terpineol multi does not need to be classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (1272/2008).