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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: - followed recognized toxicology testing procedures - GLP compliant - study results copied without further assessment from the SIDS dossier

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980
Reference Type:
secondary source
Title:
SIDS INITIAL ASSESSMENT REPORT For SIAM 18 - 1,2,3-Trichloropropane
Author:
OECD
Year:
2004
Bibliographic source:
Published OECD SIDS initial assessments of HPV chemicals: http://www.oecd.org/document/63/0,3343,en_2649_34379_1897983_1_1_1_1,00.html

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: Consistent with NAS Publication 1138 dtd 1977; Draize scoring method
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2,3-Trichloropropane
- Substance type: short-chain chlorinated hydrocarbon
- Physical state: clear colorless liquid
- Analytical purity: 98.25%
- Impurities (identity and concentrations): light ends of 0.66% and heavy ends 1.09%
- Composition of test material, percentage of components: not reported in SIDS dossier
- Purity test date: not reported in SIDS dossier
- Lot/batch No.: not reported in SIDS dossier
- Expiration date of the lot/batch: not reported in SIDS dossier
- Stability under test conditions: not reported in SIDS dossier
- Storage condition of test material: not reported in SIDS dossier

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported in SIDS dossier
- Weight at study initiation: 2 - 2.8 Kg
- Fasting period before study: not reported in SIDS dossier
- Housing: not reported in SIDS dossier
- Diet (e.g. ad libitum): not reported in SIDS dossier
- Water (e.g. ad libitum): not reported in SIDS dossier
- Acclimation period: not reported in SIDS dossier


ENVIRONMENTAL CONDITIONS
- not reported in SIDS dossier

Test system

Type of coverage:
occlusive
Preparation of test site:
other: two groups: abraded and shaved respectively
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted


VEHICLE
- no vehicle used
Duration of treatment / exposure:
24 h
Observation period:
7 d after end of exposure
Number of animals:
3 per sex and form of exposure (shaved/abraded)
Details on study design:
TEST SITE
- Area of exposure: backs were shaved and one half of the test animals were further prepared by abrading their backs (deep enough to penetrate the stratum corneum but not to the derma).
- % coverage: not reported in SIDS dossier
- Type of wrap if used: The area was wrapped with gauze and occluded with clear polyethylene film.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): backs were gently wiped with a moist towel
- Time after start of exposure: 24 h

SCORING SYSTEM:
Draize score system

The primary irritation index is calculated by the addition of erythema scores and oedema scores of all animals at observation time points, divided by the number of animals X the number of time points.


Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: not reported in detail in SIDS report, probably 24h and 72 h after end of treatment
Score:
1.63
Max. score:
3
Reversibility:
other: edema were reversible within 72 h, reversibility of erythema is not clear from the summary in the SIDS report
Irritant / corrosive response data:
Erythema was present through 72 hours in abraded skin sties, and 24 hours in unabraded sites. Edema, which was observed initially and at 24 hours, was clear by 72 hours in both groups. The severity of the response was greater in the abraded test sites. Individual scores ranged from 1-2.5 in intact skin, and from 1-3 in abraded skin sites. Overall PII was 1.63 and was mildly irritating.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The dermal irritating effects of 1,2,3-trichloropropane was tested in rabbits using a recognized scientific procedure and followed recognized GLP procedures. An overall primary irritation index for abraded and shaved skin of 1.63 was observed.
Executive summary:

In the present study (Shell Development Company, 1980c) male and female New Zealand White rabbits were treated once with 0.5 mL undiluted 1,2,3 -trichloropropane dermaly under occlusive conditions on abraded and shaved skin for 24 h and analysed for skin reactions, body weight development and clinical signs following generally the OECD TG 404 in compliance with GLP.

An overall primary irritation index (PII) for abraded and shaved skin of 1.63 was observed.

Based on this result 1,2,3 -trichloropropane is not classified regarding skin irritation according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

Undiluted test material (0.5 ml) was applied to the shaved backs of test animals; six rabbits were further prepared by abrading their backs (deep enough to penetrate the stratum corneum but not to the derma). The area was wrapped with gauze and occluded with clear polyethylene film for 24 hours. After 24 hours the bandages were removed and the test sites were observed for erythema and edema. Their backs were then gently wiped with a moist towel. All animals were again observed at 72 hours, and at day 7.

Erythema was present through 72 hours in abraded skin sites, and 24 hours in unabraded sites. Edema, which was observed initially and at 24 hours, was clear by 72 hours in both groups. The severity of the response was greater in the abraded test sites. Individual scores ranged from 1-2.5 in intact skin, and from 1-3 in abraded skin sites. Overall PII was 1.63.

The authors state the substance as mildly irritating but according to CLP no classification is needed based on this PII.