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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

 The registration substance was investigated for its irritating property according to the OECD Guideline 404 and 405. No significant irritating property was observed. No classification is warranted.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
testing stating date 1993-02-09; testing terminating date 1993-02-23; reporting date 1993-03-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically well performed study; Guideline study; GLP study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml of the test material
Duration of treatment / exposure:
4h
Observation period:
Observation at 24, 48 and 72 hours; in case of any findings at 72 hours the observation period is to be extended up to for 14 days.
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Remarks:
within 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible
Remarks:
within 14 days
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No classification is assigned for the registration substance with respect to the endpoint skin irritation.
Executive summary:

The skin irritation property of the registration substance was investigated according to the OECD Guideline 404. Three rabbits were treated topically with 0.5 ml triethylenglycoldibutylether (representative material for the registration substance). The animals exhibited transient erythema and edema that were fully reversible within 14 days of observation period. The obtained mean scores for erythema and edema were 1.3 and 0.2 respectively. Based on the obtained result the registration substance was found to be not irritating according to the EU criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
testing starting date 1993-02-03; testing terminating date 1993-03-19: reporting date 1993-04-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically well performed study; Guideline study; GLP study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Vehicle:
unchanged (no vehicle)
Controls:
other: one eye was treated and the other eye was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
Single appication
Observation period (in vivo):
Observation at 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48,72
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No classification is to be assigned to the registration substance with respect to the endpoint eye irritation.
Executive summary:

The eye irritation property of the registration substance was investigated according to the OECD Guideline 405. Triethylenglycoldibutylether (representative material for the registration substance) was given into one eye of three rabbits each at dose of 0.1 ml. The animals exhibited transient conjuctivae redness, maximal scores being one. No significant eye irritation property was found for the registration substance.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
study on the main component of the registration substance; scientifically well performed study; Gudieline study; GLP study

Justification for selection of eye irritation endpoint:
study on the main component of the registration substance; scientifically well performed study; Gudieline study; GLP study

Justification for classification or non-classification

The registration substance was investigated for its irritating property according to the OECD Guideline 404 and 405. No significant irritating property was observed. No classification is assigned to the registration substance.