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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Skin Irritation:

No category. Not requiring classification to UN GHS or EU CLP.

 

Eye irritation:

No category. Not requiring classification to UN GHS or EU CLP.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8th April 2013- 3rd July 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Skin Irritation (2-1-4), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: reputable commercial supplier
- Age at study initiation: 33-48 weeks
- Weight at study initiation:3.06 to 4.13 kg
- Housing: housed individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): Each rabbit was offered 125 g of a standard laboratory rabbit diet per day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 16-28 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20°C
- Humidity (%): 40-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12h dark/ 12h light

IN-LIFE DATES: From: To: 08 April to 03 July 2013
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g, area wetted with 0.5 mL reverse osmosis water beforehand
- Concentration (if solution): N/a

Duration of treatment / exposure:
4-hour exposure
Observation period:
4 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 100%
- Type of wrap if used: a 2-ply 25 mm x 25 mm porous gauze pad secured with ‘blenderm’ surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water (30-40°C)
- Time after start of exposure: 4 hours

SCORING SYSTEM: Local dermal irritation was assessed using the prescribed numerical system and a primary irritation index (PTI) calculated from the scores
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
There was no sign of toxicity or ill health in any rabbit during the observation period. No dermal reaction was observed in any animal throughout the duration of the study
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The Primary Irritation Index was calculated to be 0.0; T-1620Lwas classified as ‘non-irritant’ according to the criteria of the ECETOC and did not require labelling in accordance with Commission Regulation 1272/2008
Executive summary:

The Primary Irritation Index was calculated to be 0.0; T-1620Lwas classified as ‘non-irritant’ according to the criteria of the ECETOC and did not require labelling in accordance with Commission Regulation 1272/2008

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification