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Administrative data

Description of key information

Based on read-across from Alcohols, lanolin (CAS No. 8027-33-6):
Skin: not irritating (OECD 402, GLP)
Eye: not irritating (OECD 405, GLP)

Key value for chemical safety assessment

Skin irritation / corrosion

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
18 November 1980 - 12 December 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The procedure followed was a modification of that desribed by Draize
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: about 3 months
- Weight at study initiation: 2 kg
- Housing: housed in galvanised or stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Animals were acclimitised at least 3 days prior to test initiation

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
not specified
Controls:
other: yes, the other eye was used for control purposes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 h
Reading time points: 24, 48 and 72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): If any of the test article remained in the eye for 24 hours, the eye was washed out with lukewarm water after the 24 hour reading.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The test material showed no effects to either the cornea, iris or conjuctivae.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not an ocular irritant to rabbits under the conditions of the test.
CLP: not classified
DSD: not classified
Executive summary:

The test substance is not an occular irritant to rabbits under the conditions of the test.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for grouping of substances and read-across

There are no skin or eye irritation studies available for Alcohols, lanolin, distn. residues (CAS No. 90622-40-5). In order to fulfil the standard information requirements set out in Annex VIII, 8.1 and 8.2, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from an analogue substance is conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby physicochemical, toxicological and ecotoxicological properties may be predicted from data for reference substance(s) by interpolation to other substances on the basis of structural similarity, the substance Alcohols, lanolin (CAS No. 8027-33-6) is selected as reference substance for assessment of skin and eye irritation.

The read-across is mainly based on the common origin of the source and target substances, as the target substance is generated from the source substance by distillation, the target substance being the high-boiling fraction (residue) of the distillation process. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

 

Skin irritation / corrosion

In accordance with Column 2 of Annex VIII, Section 8.1.1, of Regulation (EC) No 1907/2006, an in vivo skin irritation study does not need to be conducted since, based on read-cross from the source substance Alcohols, lanolin, the available acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg bw).

Eye irritation / corrosion

The eye irritating properties of Alcohols, lanolin were tested in a GLP-compliant study conducted following a method equivalent to OECD 405 (Cade, 1980). A group of 6 rabbits was treated with the test item by a single instillation of 0.1 mL into the conjunctival of one eye, the other eye serving as control. No effects on cornea, iris or conjunctivae were observed in any animal at any reading time point (24, 48 and 72 h post-treatment). Therefore, the study was terminated at 72 h post-instillation and the test item was considered to be not irritating to the eye.

Conclusions for irritation / corrosion

There are no skin or eye irritation studies available for Alcohols, lanolin, distn. residues. In order to fulfil the standard information requirements of Annex VIII, Section 8.1 and 8.2, of Regulation (EC) No 1907/2006, hazard assessment is conducted by means of read-across from the source substance Alcohols, lanolin in accordance with Annex XI, Section 1.5.

The substance Alcohols, lanolin has been tested for acute dermal toxicity and for eye irritation in adequate and reliable studies. The acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg bw). In the in vivo eye irritation study, no effects on cornea, iris or conjunctivae were observed at any time point during the study period. The substance is thus not irritating to the skin or eye.

Based on the read-across approach, the substance Alcohols, lanolin, distn. residues is considered to be not irritating to the skin or eye.


Justification for selection of skin irritation / corrosion endpoint:
No study required since, based on read-cross from an anlogue substance/surrogate, the available acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg bw).

Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from a structural analogue/surrogate. The selected study is the most adequate and reliable study based on the identified similarities in structure/composition and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).

Justification for classification or non-classification

Based on read-across from the source substance Alcohols, lanolin (CAS No. 8027-33-6) following an analogue approach, the available data on the skin and eye irritation properties of Alcohols, lanolin, distn. residues do nor meet the classification criteria according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.